Difference between revisions of "Estrada"

(Created page with " <span style="font-size:x-large;">'''<span style="font-family:" times="" new="" roman",serif"="">Hyperbaric oxygen in combination with autologous bone marrow stem cell transpl...")
 
 
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<span style="font-size:x-large;">'''<span style="font-family:" times="" new="" roman",serif"="">Hyperbaric oxygen in combination with autologous bone marrow stem cell transplant improved HbA1c, pancreatic function and reduced insulin requirements in type 2 diabetic patients.</span>'''</span>
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<span style="font-size:x-large;">'''<span style="font-family:">Hyperbaric oxygen in combination with autologous bone marrow stem cell transplant improved HbA1c, pancreatic function and reduced insulin requirements in type 2 diabetic patients.</span>'''</span>
  
 
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'''<span style="font-size:14.0pt"><span style="font-family:" times="" new="" roman",serif"="">Clinical bottom line:</span></span>'''
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'''<span style="font-size:14.0pt"><span style="font-family:">Clinical bottom line:</span></span>'''
  
#<span style="font-family:" times="" new="" roman",serif"="">HBO in combination with stem cell transplant improved HBA1c, glucose and C-peptide levels and reduced insulin requirements</span>  
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#<span style="font-family:">HBO in combination with stem cell transplant improved HBA1c, glucose and C-peptide levels and reduced insulin requirements</span>  
  
'''<span style="font-family:" times="" new="" roman",serif"="">Citation/s:</span>'''<span style="font-family:" times="" new="" roman",serif"="">1. Estrada EJ, Decima JL, Bortman G, Roberti J, Romero EB, Samaja G, Saavedra AR, Martinez G, Gutierrez S. Combination treatment of autologous bone marrow stem cell transplantation and hyperbaric oxygen therapy for type 2 diabetes mellitus: A randomised controlled trial. Cell Transplantation. 2019, 28(12), 1632-1640.</span>
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'''<span style="font-family:">Citation/s:</span>'''<span style="font-family:">1. Estrada EJ, Decima JL, Bortman G, Roberti J, Romero EB, Samaja G, Saavedra AR, Martinez G, Gutierrez S. Combination treatment of autologous bone marrow stem cell transplantation and hyperbaric oxygen therapy for type 2 diabetes mellitus: A randomised controlled trial. Cell Transplantation. 2019, 28(12), 1632-1640.</span>
  
 
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'''<span style="font-family:" times="" new="" roman",serif"="">Lead author’s name and fax:</span>'''<span style="font-family:" times="" new="" roman",serif"="">J. Roberti : javierroberti@gmail.com</span>
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'''<span style="font-family:">Lead author’s name and fax:</span>'''<span style="font-family:">J. Roberti&nbsp;: javierroberti@gmail.com</span>
  
'''<span style="font-family:" times="" new="" roman",serif"="">Three-part Clinical Question:</span>'''<span style="font-family:" times="" new="" roman",serif"="">In type 2 diabetic patients, does hyperbaric oxygen in combination with intrapancreatic autologous stem cell transplantation result in improved metabolic control as compared to standard pharmacological therapy alone?</span>
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'''<span style="font-family:">Three-part Clinical Question:</span>'''<span style="font-family:">In type 2 diabetic patients, does hyperbaric oxygen in combination with intrapancreatic autologous stem cell transplantation result in improved metabolic control as compared to standard pharmacological therapy alone?</span>
  
'''<span style="font-family:" times="" new="" roman",serif"="">Search Terms:</span>'''<span style="font-family:" times="" new="" roman",serif"="">Type 2 diabetes; stem cell therapy; autologous transplantation</span>
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'''<span style="font-family:">Search Terms:</span>'''<span style="font-family:">Type 2 diabetes; stem cell therapy; autologous transplantation</span>
  
 
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'''<span style="font-family:" times="" new="" roman",serif"="">The Study:</span>'''<span style="font-family:" times="" new="" roman",serif"="">Non-blinded non-concealed randomised controlled trial with intention-to-treat.</span>
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'''<span style="font-family:">The Study:</span>'''<span style="font-family:">Non-blinded non-concealed randomised controlled trial with intention-to-treat.</span>
  
'''<span style="font-family:" times="" new="" roman",serif"="">The Study Patients:</span>'''<span style="font-family:" times="" new="" roman",serif"="">Adult type 2 diabetic patients who had been previously treated with a medical therapy regimen including insulin. Patients with a BMI >35, insulin requirement >100 U/day, HbA1c >9.5% or glutamate decarboxylase seropositivity were excluded from the study.</span>
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'''<span style="font-family:">The Study Patients:</span>'''<span style="font-family:">Adult type 2 diabetic patients who had been previously treated with a medical therapy regimen including insulin. Patients with a BMI >35, insulin requirement >100 U/day, HbA1c >9.5% or glutamate decarboxylase seropositivity were excluded from the study.</span>
  
'''<span style="font-family:" times="" new="" roman",serif"="">Control group</span>'''<span style="font-family:" times="" new="" roman",serif"="">(N = 10; 10 analysed): Anti-hyperglycaemic therapy as per endocrinologist advice in line with American Diabetes Association Guidelines as well as statin therapy and aspirin unless contraindicated.</span>
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'''<span style="font-family:">Control group</span>'''<span style="font-family:">(N = 10; 10 analysed): Anti-hyperglycaemic therapy as per endocrinologist advice in line with American Diabetes Association Guidelines as well as statin therapy and aspirin unless contraindicated.</span>
  
'''<span style="font-family:" times="" new="" roman",serif"="">Experimental group</span>'''<span style="font-family:" times="" new="" roman",serif"="">(N = 13; 13 analysed): Anti-hyperglycaemic, statin and aspirin therapy as in the control group, HBOT 100% O2 at 2.5 ATA for 10 sessions over 3 weeks, and intra-arterial pancreatic autologous stem cell infusion.</span>
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'''<span style="font-family:">Experimental group</span>'''<span style="font-family:">(N = 13; 13 analysed): Anti-hyperglycaemic, statin and aspirin therapy as in the control group, HBOT 100% O2 at 2.5 ATA for 10 sessions over 3 weeks, and intra-arterial pancreatic autologous stem cell infusion.</span>
  
'''<span style="font-family:" times="" new="" roman",serif"="">The Evidence:</span>'''
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'''<span style="font-family:">The Evidence:</span>'''
  
 
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{| class="Table" style="width: 757px; border: 1pt solid windowtext;" width="0"
 
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| style="width: 172px; border: 1pt solid windowtext;" width="123" |  
 
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'''<span style="font-size:11.0pt"><span style="font-family:" times="" new="" roman",serif"="">Outcome</span></span>'''
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'''<span style="font-size:11.0pt"><span style="font-family:">Outcome</span></span>'''
  
| style="width: 74px; border: 1pt solid windowtext;" width="66" | <p align="center" style="text-align:center; padding:.75pt .75pt .75pt .75pt">'''<span style="font-size:11.0pt"><span style="font-family:" times="" new="" roman",serif"="">Time to Outcome</span></span>'''</p>  
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| style="width: 74px; border: 1pt solid windowtext;" width="66" | <p align="center" style="text-align:center; padding:.75pt .75pt .75pt .75pt">'''<span style="font-size:11.0pt"><span style="font-family:">Time to Outcome</span></span>'''</p>  
| style="width: 75px; border: 1pt solid windowtext;" width="57" | <p align="center" style="text-align:center; padding:.75pt .75pt .75pt .75pt">'''<span style="font-size:11.0pt"><span style="font-family:" times="" new="" roman",serif"="">Control group</span></span>'''</p>  
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| style="width: 75px; border: 1pt solid windowtext;" width="57" | <p align="center" style="text-align:center; padding:.75pt .75pt .75pt .75pt">'''<span style="font-size:11.0pt"><span style="font-family:">Control group</span></span>'''</p>  
| style="width: 100px; border: 1pt solid windowtext;" width="104" | <p align="center" style="text-align:center; padding:.75pt .75pt .75pt .75pt">'''<span style="font-size:11.0pt"><span style="font-family:" times="" new="" roman",serif"="">HBO and stem cell group</span></span>'''</p>  
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| style="width: 100px; border: 1pt solid windowtext;" width="104" | <p align="center" style="text-align:center; padding:.75pt .75pt .75pt .75pt">'''<span style="font-size:11.0pt"><span style="font-family:">HBO and stem cell group</span></span>'''</p>  
| style="width: 106px; border: 1pt solid windowtext;" width="95" | <p align="center" style="text-align:center; padding:.75pt .75pt .75pt .75pt">'''<span style="font-size:11.0pt"><span style="font-family:" times="" new="" roman",serif"="">Relative Risk Reduction</span></span>'''</p>  
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| style="width: 106px; border: 1pt solid windowtext;" width="95" | <p align="center" style="text-align:center; padding:.75pt .75pt .75pt .75pt">'''<span style="font-size:11.0pt"><span style="font-family:">Relative Risk Reduction</span></span>'''</p>  
| style="width: 103px; border: 1pt solid windowtext;" width="94" | <p align="center" style="text-align:center; padding:.75pt .75pt .75pt .75pt">'''<span style="font-size:11.0pt"><span style="font-family:" times="" new="" roman",serif"="">Absolute Risk Reduction</span></span>'''</p>  
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| style="width: 103px; border: 1pt solid windowtext;" width="94" | <p align="center" style="text-align:center; padding:.75pt .75pt .75pt .75pt">'''<span style="font-size:11.0pt"><span style="font-family:">Absolute Risk Reduction</span></span>'''</p>  
| style="width: 73px; border: 1pt solid windowtext;" width="66" | <p align="center" style="text-align:center; padding:.75pt .75pt .75pt .75pt">'''<span style="font-size:11.0pt"><span style="font-family:" times="" new="" roman",serif"="">NNT</span></span>'''</p>  
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| style="width: 73px; border: 1pt solid windowtext;" width="66" | <p align="center" style="text-align:center; padding:.75pt .75pt .75pt .75pt">'''<span style="font-size:11.0pt"><span style="font-family:">NNT</span></span>'''</p>  
 
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| rowspan="2" style="width: 172px; border: 1pt solid windowtext;" width="123" |  
 
| rowspan="2" style="width: 172px; border: 1pt solid windowtext;" width="123" |  
'''<span style="font-size:11.0pt"><span style="font-family:" times="" new="" roman",serif"="">HbA1c reduction at least 1% (180 days)</span></span>'''
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'''<span style="font-size:11.0pt"><span style="font-family:">HbA1c reduction at least 1% (180 days)</span></span>'''
  
| style="width: 74px; border: 1pt solid windowtext;" width="66" | <p align="center" style="text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="font-size:11.0pt"><span style="font-family:" times="" new="" roman",serif"="">180 days</span></span></p>  
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| style="width: 74px; border: 1pt solid windowtext;" width="66" | <p align="center" style="text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="font-size:11.0pt"><span style="font-family:">180 days</span></span></p>  
| style="width: 75px; border: 1pt solid windowtext;" width="57" | <p align="center" style="text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="font-size:11.0pt"><span style="font-family:" times="" new="" roman",serif"="">0.3</span></span></p>  
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| style="width: 75px; border: 1pt solid windowtext;" width="57" | <p align="center" style="text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="font-size:11.0pt"><span style="font-family:">0.3</span></span></p>  
| style="width: 100px; border: 1pt solid windowtext;" width="104" | <p align="center" style="text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="font-size:11.0pt"><span style="font-family:" times="" new="" roman",serif"="">0.77</span></span></p>  
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| style="width: 100px; border: 1pt solid windowtext;" width="104" | <p align="center" style="text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="font-size:11.0pt"><span style="font-family:">0.77</span></span></p>  
| style="width: 106px; border: 1pt solid windowtext;" width="95" | <p align="center" style="text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="font-size:11.0pt"><span style="font-family:" times="" new="" roman",serif"="">156%</span></span></p>  
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| style="width: 106px; border: 1pt solid windowtext;" width="95" | <p align="center" style="text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="font-size:11.0pt"><span style="font-family:">156%</span></span></p>  
| style="width: 103px; border: 1pt solid windowtext;" width="94" | <p align="center" style="text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="font-size:11.0pt"><span style="font-family:" times="" new="" roman",serif"="">0.47</span></span></p>  
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| style="width: 103px; border: 1pt solid windowtext;" width="94" | <p align="center" style="text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="font-size:11.0pt"><span style="font-family:">0.47</span></span></p>  
| style="width: 73px; border: 1pt solid windowtext;" width="66" | <p align="center" style="text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="font-size:11.0pt"><span style="font-family:" times="" new="" roman",serif"="">2</span></span></p>  
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| style="width: 73px; border: 1pt solid windowtext;" width="66" | <p align="center" style="text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="font-size:11.0pt"><span style="font-family:">2</span></span></p>  
 
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| colspan="3" style="width: 264px; border: 1pt solid windowtext;" width="227" | <p align="right" style="text-align:right; padding:.75pt .75pt .75pt .75pt"><span style="font-size:11.0pt"><span style="font-family:" times="" new="" roman",serif"="">95% CI:</span></span></p>  
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| colspan="3" style="width: 264px; border: 1pt solid windowtext;" width="227" | <p align="right" style="text-align:right; padding:.75pt .75pt .75pt .75pt"><span style="font-size:11.0pt"><span style="font-family:">95% CI:</span></span></p>  
| style="width: 106px; border: 1pt solid windowtext;" width="95" | <p align="center" style="text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="font-size:11.0pt"><span style="font-family:" times="" new="" roman",serif"="">35% to 278%</span></span></p>  
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| style="width: 106px; border: 1pt solid windowtext;" width="95" | <p align="center" style="text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="font-size:11.0pt"><span style="font-family:">35% to 278%</span></span></p>  
| style="width: 103px; border: 1pt solid windowtext;" width="94" | <p align="center" style="text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="font-size:11.0pt"><span style="font-family:" times="" new="" roman",serif"="">0.1 to 0.8</span></span></p>  
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| style="width: 103px; border: 1pt solid windowtext;" width="94" | <p align="center" style="text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="font-size:11.0pt"><span style="font-family:">0.1 to 0.8</span></span></p>  
| style="width: 73px; border: 1pt solid windowtext;" width="66" | <p align="center" style="text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="font-size:11.0pt"><span style="font-family:" times="" new="" roman",serif"="">1 to 10</span></span></p>  
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| style="width: 73px; border: 1pt solid windowtext;" width="66" | <p align="center" style="text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="font-size:11.0pt"><span style="font-family:">1 to 10</span></span></p>  
 
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<span style="height:18.15pt">'''<span style="font-size:11.0pt"><span style="font-family:" times="" new="" roman",serif"="">Measure</span></span>'''</span>
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<span style="height:18.15pt">'''<span style="font-size:11.0pt"><span style="font-family:">Measure</span></span>'''</span>
  
| colspan="2" style="width: 144px; border-top: 1pt solid windowtext; border-right: 1pt solid windowtext; border-bottom: 1pt solid windowtext; border-image: initial; border-left: none;" width="115" | <p align="center" style="text-align:center; padding:0cm 5.4pt 0cm 5.4pt"><span style="height:18.15pt">'''<span style="font-size:11.0pt"><span style="font-family:" times="" new="" roman",serif"="">Control Group</span></span>'''</span></p>  
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| colspan="2" style="width: 144px; border-top: 1pt solid windowtext; border-right: 1pt solid windowtext; border-bottom: 1pt solid windowtext; border-image: initial; border-left: none;" width="115" | <p align="center" style="text-align:center; padding:0cm 5.4pt 0cm 5.4pt"><span style="height:18.15pt">'''<span style="font-size:11.0pt"><span style="font-family:">Control Group</span></span>'''</span></p>  
| colspan="2" style="width: 156px; border-top: 1pt solid windowtext; border-right: 1pt solid windowtext; border-bottom: 1pt solid windowtext; border-image: initial; border-left: none;" width="111" | <p align="center" style="text-align:center; padding:0cm 5.4pt 0cm 5.4pt"><span style="height:18.15pt">'''<span style="font-size:11.0pt"><span style="font-family:" times="" new="" roman",serif"="">HBOT and stem cell&nbsp; Group</span></span>'''</span></p>  
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| colspan="2" style="width: 156px; border-top: 1pt solid windowtext; border-right: 1pt solid windowtext; border-bottom: 1pt solid windowtext; border-image: initial; border-left: none;" width="111" | <p align="center" style="text-align:center; padding:0cm 5.4pt 0cm 5.4pt"><span style="height:18.15pt">'''<span style="font-size:11.0pt"><span style="font-family:">HBOT and stem cell&nbsp; Group</span></span>'''</span></p>  
| rowspan="2" style="width: 80px; border-top: 1pt solid windowtext; border-right: 1pt solid windowtext; border-bottom: 1pt solid windowtext; border-image: initial; border-left: none;" width="84" | <p align="center" style="text-align:center; padding:0cm 5.4pt 0cm 5.4pt"><span style="height:18.15pt">'''<span style="font-size:11.0pt"><span style="font-family:" times="" new="" roman",serif"="">Difference</span></span>'''</span></p>  
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| rowspan="2" style="width: 80px; border-top: 1pt solid windowtext; border-right: 1pt solid windowtext; border-bottom: 1pt solid windowtext; border-image: initial; border-left: none;" width="84" | <p align="center" style="text-align:center; padding:0cm 5.4pt 0cm 5.4pt"><span style="height:18.15pt">'''<span style="font-size:11.0pt"><span style="font-family:">Difference</span></span>'''</span></p>  
| rowspan="2" style="width: 90px; border-top: 1pt solid windowtext; border-right: 1pt solid windowtext; border-bottom: 1pt solid windowtext; border-image: initial; border-left: none;" width="84" | <p align="center" style="text-align:center; padding:0cm 5.4pt 0cm 5.4pt"><span style="height:18.15pt">'''<span style="font-size:11.0pt"><span style="font-family:" times="" new="" roman",serif"="">95% CI</span></span>'''</span></p>  
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| rowspan="2" style="width: 90px; border-top: 1pt solid windowtext; border-right: 1pt solid windowtext; border-bottom: 1pt solid windowtext; border-image: initial; border-left: none;" width="84" | <p align="center" style="text-align:center; padding:0cm 5.4pt 0cm 5.4pt"><span style="height:18.15pt">'''<span style="font-size:11.0pt"><span style="font-family:">95% CI</span></span>'''</span></p>  
 
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| style="width: 83px; border-top: none; border-left: none; border-bottom: 1pt solid windowtext; border-right: 1pt solid windowtext;" width="73" | <p align="center" style="text-align:center; padding:0cm 5.4pt 0cm 5.4pt"><span style="height:33.5pt">'''<span style="font-size:11.0pt"><span style="font-family:" times="" new="" roman",serif"="">Mean</span></span>'''</span></p>  
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| style="width: 83px; border-top: none; border-left: none; border-bottom: 1pt solid windowtext; border-right: 1pt solid windowtext;" width="73" | <p align="center" style="text-align:center; padding:0cm 5.4pt 0cm 5.4pt"><span style="height:33.5pt">'''<span style="font-size:11.0pt"><span style="font-family:">Mean</span></span>'''</span></p>  
| style="width: 58px; border-top: none; border-left: none; border-bottom: 1pt solid windowtext; border-right: 1pt solid windowtext;" width="42" | <p align="center" style="text-align:center; padding:0cm 5.4pt 0cm 5.4pt"><span style="height:33.5pt">'''<span style="font-size:11.0pt"><span style="font-family:" times="" new="" roman",serif"="">SD</span></span>'''</span></p>  
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| style="width: 58px; border-top: none; border-left: none; border-bottom: 1pt solid windowtext; border-right: 1pt solid windowtext;" width="42" | <p align="center" style="text-align:center; padding:0cm 5.4pt 0cm 5.4pt"><span style="height:33.5pt">'''<span style="font-size:11.0pt"><span style="font-family:">SD</span></span>'''</span></p>  
| style="width: 109px; border-top: none; border-left: none; border-bottom: 1pt solid windowtext; border-right: 1pt solid windowtext;" width="66" | <p align="center" style="text-align:center; padding:0cm 5.4pt 0cm 5.4pt"><span style="height:33.5pt">'''<span style="font-size:11.0pt"><span style="font-family:" times="" new="" roman",serif"="">Mean</span></span>'''</span></p>  
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| style="width: 109px; border-top: none; border-left: none; border-bottom: 1pt solid windowtext; border-right: 1pt solid windowtext;" width="66" | <p align="center" style="text-align:center; padding:0cm 5.4pt 0cm 5.4pt"><span style="height:33.5pt">'''<span style="font-size:11.0pt"><span style="font-family:">Mean</span></span>'''</span></p>  
| style="width: 44px; border-top: none; border-left: none; border-bottom: 1pt solid windowtext; border-right: 1pt solid windowtext;" width="45" | <p align="center" style="text-align:center; padding:0cm 5.4pt 0cm 5.4pt"><span style="height:33.5pt">'''<span style="font-size:11.0pt"><span style="font-family:" times="" new="" roman",serif"="">SD</span></span>'''</span></p>  
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| style="width: 44px; border-top: none; border-left: none; border-bottom: 1pt solid windowtext; border-right: 1pt solid windowtext;" width="45" | <p align="center" style="text-align:center; padding:0cm 5.4pt 0cm 5.4pt"><span style="height:33.5pt">'''<span style="font-size:11.0pt"><span style="font-family:">SD</span></span>'''</span></p>  
 
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|- style="height:15.5pt"
 
| style="width: 268px; border-right: 1pt solid windowtext; border-bottom: 1pt solid windowtext; border-left: 1pt solid windowtext; border-image: initial; border-top: none;" width="206" |  
 
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<span style="height:15.5pt">'''<span style="font-size:11.0pt"><span style="font-family:" times="" new="" roman",serif"="">HbA1c (%) at 365 days</span></span>'''</span>
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<span style="height:15.5pt">'''<span style="font-size:11.0pt"><span style="font-family:">HbA1c (%) at 365 days</span></span>'''</span>
  
| style="width: 83px; border-top: none; border-left: none; border-bottom: 1pt solid windowtext; border-right: 1pt solid windowtext;" width="73" | <p align="center" style="text-align:center; padding:0cm 5.4pt 0cm 5.4pt"><span style="height:15.5pt"><span style="font-size:11.0pt"><span style="font-family:" times="" new="" roman",serif"="">8.0</span></span></span></p>  
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| style="width: 83px; border-top: none; border-left: none; border-bottom: 1pt solid windowtext; border-right: 1pt solid windowtext;" width="73" | <p align="center" style="text-align:center; padding:0cm 5.4pt 0cm 5.4pt"><span style="height:15.5pt"><span style="font-size:11.0pt"><span style="font-family:">8.0</span></span></span></p>  
| style="width: 58px; border-top: none; border-left: none; border-bottom: 1pt solid windowtext; border-right: 1pt solid windowtext;" width="42" | <p align="center" style="text-align:center; padding:0cm 5.4pt 0cm 5.4pt"><span style="height:15.5pt"><span style="font-size:11.0pt"><span style="font-family:" times="" new="" roman",serif"="">0.7</span></span></span></p>  
+
| style="width: 58px; border-top: none; border-left: none; border-bottom: 1pt solid windowtext; border-right: 1pt solid windowtext;" width="42" | <p align="center" style="text-align:center; padding:0cm 5.4pt 0cm 5.4pt"><span style="height:15.5pt"><span style="font-size:11.0pt"><span style="font-family:">0.7</span></span></span></p>  
| style="width: 109px; border-top: none; border-left: none; border-bottom: 1pt solid windowtext; border-right: 1pt solid windowtext;" width="66" | <p align="center" style="text-align:center; padding:0cm 5.4pt 0cm 5.4pt"><span style="height:15.5pt"><span style="font-size:11.0pt"><span style="font-family:" times="" new="" roman",serif"="">7.3</span></span></span></p>  
+
| style="width: 109px; border-top: none; border-left: none; border-bottom: 1pt solid windowtext; border-right: 1pt solid windowtext;" width="66" | <p align="center" style="text-align:center; padding:0cm 5.4pt 0cm 5.4pt"><span style="height:15.5pt"><span style="font-size:11.0pt"><span style="font-family:">7.3</span></span></span></p>  
| style="width: 44px; border-top: none; border-left: none; border-bottom: 1pt solid windowtext; border-right: 1pt solid windowtext;" width="45" | <p align="center" style="text-align:center; padding:0cm 5.4pt 0cm 5.4pt"><span style="height:15.5pt"><span style="font-size:11.0pt"><span style="font-family:" times="" new="" roman",serif"="">0.9</span></span></span></p>  
+
| style="width: 44px; border-top: none; border-left: none; border-bottom: 1pt solid windowtext; border-right: 1pt solid windowtext;" width="45" | <p align="center" style="text-align:center; padding:0cm 5.4pt 0cm 5.4pt"><span style="height:15.5pt"><span style="font-size:11.0pt"><span style="font-family:">0.9</span></span></span></p>  
| style="width: 80px; border-top: none; border-left: none; border-bottom: 1pt solid windowtext; border-right: 1pt solid windowtext;" width="84" | <p align="center" style="text-align:center; padding:0cm 5.4pt 0cm 5.4pt"><span style="height:15.5pt"><span style="font-size:11.0pt"><span style="font-family:" times="" new="" roman",serif"="">0.7</span></span></span></p>  
+
| style="width: 80px; border-top: none; border-left: none; border-bottom: 1pt solid windowtext; border-right: 1pt solid windowtext;" width="84" | <p align="center" style="text-align:center; padding:0cm 5.4pt 0cm 5.4pt"><span style="height:15.5pt"><span style="font-size:11.0pt"><span style="font-family:">0.7</span></span></span></p>  
| style="width: 90px; border-top: none; border-left: none; border-bottom: 1pt solid windowtext; border-right: 1pt solid windowtext;" width="84" | <p align="center" style="text-align:center; padding:0cm 5.4pt 0cm 5.4pt"><span style="height:15.5pt"><span style="font-size:11.0pt"><span style="font-family:" times="" new="" roman",serif"="">0.1 to 1.3</span></span></span></p>  
+
| style="width: 90px; border-top: none; border-left: none; border-bottom: 1pt solid windowtext; border-right: 1pt solid windowtext;" width="84" | <p align="center" style="text-align:center; padding:0cm 5.4pt 0cm 5.4pt"><span style="height:15.5pt"><span style="font-size:11.0pt"><span style="font-family:">0.1 to 1.3</span></span></span></p>  
 
|- style="height:15.5pt"
 
|- style="height:15.5pt"
 
| style="width: 268px; border-right: 1pt solid windowtext; border-bottom: 1pt solid windowtext; border-left: 1pt solid windowtext; border-image: initial; border-top: none;" width="206" |  
 
| style="width: 268px; border-right: 1pt solid windowtext; border-bottom: 1pt solid windowtext; border-left: 1pt solid windowtext; border-image: initial; border-top: none;" width="206" |  
<span style="height:15.5pt">'''<span style="font-size:11.0pt"><span style="font-family:" times="" new="" roman",serif"="">Glucose (mmol/L) at 90 days</span></span>'''</span>
+
<span style="height:15.5pt">'''<span style="font-size:11.0pt"><span style="font-family:">Glucose (mmol/L) at 90 days</span></span>'''</span>
  
| style="width: 83px; border-top: none; border-left: none; border-bottom: 1pt solid windowtext; border-right: 1pt solid windowtext;" width="73" | <p align="center" style="text-align:center; padding:0cm 5.4pt 0cm 5.4pt"><span style="height:15.5pt"><span style="font-size:11.0pt"><span style="font-family:" times="" new="" roman",serif"="">9.9</span></span></span></p>  
+
| style="width: 83px; border-top: none; border-left: none; border-bottom: 1pt solid windowtext; border-right: 1pt solid windowtext;" width="73" | <p align="center" style="text-align:center; padding:0cm 5.4pt 0cm 5.4pt"><span style="height:15.5pt"><span style="font-size:11.0pt"><span style="font-family:">9.9</span></span></span></p>  
| style="width: 58px; border-top: none; border-left: none; border-bottom: 1pt solid windowtext; border-right: 1pt solid windowtext;" width="42" | <p align="center" style="text-align:center; padding:0cm 5.4pt 0cm 5.4pt"><span style="height:15.5pt"><span style="font-size:11.0pt"><span style="font-family:" times="" new="" roman",serif"="">1.0</span></span></span></p>  
+
| style="width: 58px; border-top: none; border-left: none; border-bottom: 1pt solid windowtext; border-right: 1pt solid windowtext;" width="42" | <p align="center" style="text-align:center; padding:0cm 5.4pt 0cm 5.4pt"><span style="height:15.5pt"><span style="font-size:11.0pt"><span style="font-family:">1.0</span></span></span></p>  
| style="width: 109px; border-top: none; border-left: none; border-bottom: 1pt solid windowtext; border-right: 1pt solid windowtext;" width="66" | <p align="center" style="text-align:center; padding:0cm 5.4pt 0cm 5.4pt"><span style="height:15.5pt"><span style="font-size:11.0pt"><span style="font-family:" times="" new="" roman",serif"="">6.7</span></span></span></p>  
+
| style="width: 109px; border-top: none; border-left: none; border-bottom: 1pt solid windowtext; border-right: 1pt solid windowtext;" width="66" | <p align="center" style="text-align:center; padding:0cm 5.4pt 0cm 5.4pt"><span style="height:15.5pt"><span style="font-size:11.0pt"><span style="font-family:">6.7</span></span></span></p>  
| style="width: 44px; border-top: none; border-left: none; border-bottom: 1pt solid windowtext; border-right: 1pt solid windowtext;" width="45" | <p align="center" style="text-align:center; padding:0cm 5.4pt 0cm 5.4pt"><span style="height:15.5pt"><span style="font-size:11.0pt"><span style="font-family:" times="" new="" roman",serif"="">1.5</span></span></span></p>  
+
| style="width: 44px; border-top: none; border-left: none; border-bottom: 1pt solid windowtext; border-right: 1pt solid windowtext;" width="45" | <p align="center" style="text-align:center; padding:0cm 5.4pt 0cm 5.4pt"><span style="height:15.5pt"><span style="font-size:11.0pt"><span style="font-family:">1.5</span></span></span></p>  
| style="width: 80px; border-top: none; border-left: none; border-bottom: 1pt solid windowtext; border-right: 1pt solid windowtext;" width="84" | <p align="center" style="text-align:center; padding:0cm 5.4pt 0cm 5.4pt"><span style="height:15.5pt"><span style="font-size:11.0pt"><span style="font-family:" times="" new="" roman",serif"="">3.2</span></span></span></p>  
+
| style="width: 80px; border-top: none; border-left: none; border-bottom: 1pt solid windowtext; border-right: 1pt solid windowtext;" width="84" | <p align="center" style="text-align:center; padding:0cm 5.4pt 0cm 5.4pt"><span style="height:15.5pt"><span style="font-size:11.0pt"><span style="font-family:">3.2</span></span></span></p>  
| style="width: 90px; border-top: none; border-left: none; border-bottom: 1pt solid windowtext; border-right: 1pt solid windowtext;" width="84" | <p align="center" style="text-align:center; padding:0cm 5.4pt 0cm 5.4pt"><span style="height:15.5pt"><span style="font-size:11.0pt"><span style="font-family:" times="" new="" roman",serif"="">1.7 to 4.7</span></span></span></p>  
+
| style="width: 90px; border-top: none; border-left: none; border-bottom: 1pt solid windowtext; border-right: 1pt solid windowtext;" width="84" | <p align="center" style="text-align:center; padding:0cm 5.4pt 0cm 5.4pt"><span style="height:15.5pt"><span style="font-size:11.0pt"><span style="font-family:">1.7 to 4.7</span></span></span></p>  
 
|- style="height:15.5pt"
 
|- style="height:15.5pt"
 
| style="width: 268px; border-right: 1pt solid windowtext; border-bottom: 1pt solid windowtext; border-left: 1pt solid windowtext; border-image: initial; border-top: none;" width="206" |  
 
| style="width: 268px; border-right: 1pt solid windowtext; border-bottom: 1pt solid windowtext; border-left: 1pt solid windowtext; border-image: initial; border-top: none;" width="206" |  
<span style="height:15.5pt">'''<span style="font-size:11.0pt"><span style="font-family:" times="" new="" roman",serif"="">C-peptide (ng/ml)</span></span>'''</span>
+
<span style="height:15.5pt">'''<span style="font-size:11.0pt"><span style="font-family:">C-peptide (ng/ml)</span></span>'''</span>
  
| style="width: 83px; border-top: none; border-left: none; border-bottom: 1pt solid windowtext; border-right: 1pt solid windowtext;" width="73" | <p align="center" style="text-align:center; padding:0cm 5.4pt 0cm 5.4pt"><span style="height:15.5pt"><span style="font-size:11.0pt"><span style="font-family:" times="" new="" roman",serif"="">0.7</span></span></span></p>  
+
| style="width: 83px; border-top: none; border-left: none; border-bottom: 1pt solid windowtext; border-right: 1pt solid windowtext;" width="73" | <p align="center" style="text-align:center; padding:0cm 5.4pt 0cm 5.4pt"><span style="height:15.5pt"><span style="font-size:11.0pt"><span style="font-family:">0.7</span></span></span></p>  
| style="width: 58px; border-top: none; border-left: none; border-bottom: 1pt solid windowtext; border-right: 1pt solid windowtext;" width="42" | <p align="center" style="text-align:center; padding:0cm 5.4pt 0cm 5.4pt"><span style="height:15.5pt"><span style="font-size:11.0pt"><span style="font-family:" times="" new="" roman",serif"="">0.4</span></span></span></p>  
+
| style="width: 58px; border-top: none; border-left: none; border-bottom: 1pt solid windowtext; border-right: 1pt solid windowtext;" width="42" | <p align="center" style="text-align:center; padding:0cm 5.4pt 0cm 5.4pt"><span style="height:15.5pt"><span style="font-size:11.0pt"><span style="font-family:">0.4</span></span></span></p>  
| style="width: 109px; border-top: none; border-left: none; border-bottom: 1pt solid windowtext; border-right: 1pt solid windowtext;" width="66" | <p align="center" style="text-align:center; padding:0cm 5.4pt 0cm 5.4pt"><span style="height:15.5pt"><span style="font-size:11.0pt"><span style="font-family:" times="" new="" roman",serif"="">1.9</span></span></span></p>  
+
| style="width: 109px; border-top: none; border-left: none; border-bottom: 1pt solid windowtext; border-right: 1pt solid windowtext;" width="66" | <p align="center" style="text-align:center; padding:0cm 5.4pt 0cm 5.4pt"><span style="height:15.5pt"><span style="font-size:11.0pt"><span style="font-family:">1.9</span></span></span></p>  
| style="width: 44px; border-top: none; border-left: none; border-bottom: 1pt solid windowtext; border-right: 1pt solid windowtext;" width="45" | <p align="center" style="text-align:center; padding:0cm 5.4pt 0cm 5.4pt"><span style="height:15.5pt"><span style="font-size:11.0pt"><span style="font-family:" times="" new="" roman",serif"="">1.0</span></span></span></p>  
+
| style="width: 44px; border-top: none; border-left: none; border-bottom: 1pt solid windowtext; border-right: 1pt solid windowtext;" width="45" | <p align="center" style="text-align:center; padding:0cm 5.4pt 0cm 5.4pt"><span style="height:15.5pt"><span style="font-size:11.0pt"><span style="font-family:">1.0</span></span></span></p>  
| style="width: 80px; border-top: none; border-left: none; border-bottom: 1pt solid windowtext; border-right: 1pt solid windowtext;" width="84" | <p align="center" style="text-align:center; padding:0cm 5.4pt 0cm 5.4pt"><span style="height:15.5pt"><span style="font-size:11.0pt"><span style="font-family:" times="" new="" roman",serif"="">1.2</span></span></span></p>  
+
| style="width: 80px; border-top: none; border-left: none; border-bottom: 1pt solid windowtext; border-right: 1pt solid windowtext;" width="84" | <p align="center" style="text-align:center; padding:0cm 5.4pt 0cm 5.4pt"><span style="height:15.5pt"><span style="font-size:11.0pt"><span style="font-family:">1.2</span></span></span></p>  
| style="width: 90px; border-top: none; border-left: none; border-bottom: 1pt solid windowtext; border-right: 1pt solid windowtext;" width="84" | <p align="center" style="text-align:center; padding:0cm 5.4pt 0cm 5.4pt"><span style="height:15.5pt"><span style="font-size:11.0pt"><span style="font-family:" times="" new="" roman",serif"="">0.6 to 1.8</span></span></span></p>  
+
| style="width: 90px; border-top: none; border-left: none; border-bottom: 1pt solid windowtext; border-right: 1pt solid windowtext;" width="84" | <p align="center" style="text-align:center; padding:0cm 5.4pt 0cm 5.4pt"><span style="height:15.5pt"><span style="font-size:11.0pt"><span style="font-family:">0.6 to 1.8</span></span></span></p>  
 
|- style="height:15.5pt"
 
|- style="height:15.5pt"
 
| style="width: 268px; border-right: 1pt solid windowtext; border-bottom: 1pt solid windowtext; border-left: 1pt solid windowtext; border-image: initial; border-top: none;" width="206" |  
 
| style="width: 268px; border-right: 1pt solid windowtext; border-bottom: 1pt solid windowtext; border-left: 1pt solid windowtext; border-image: initial; border-top: none;" width="206" |  
<span style="height:15.5pt">'''<span style="font-size:11.0pt"><span style="font-family:" times="" new="" roman",serif"="">Insulin requirement (u/24hrs) 180 days</span></span>'''</span>
+
<span style="height:15.5pt">'''<span style="font-size:11.0pt"><span style="font-family:">Insulin requirement (u/24hrs) 180 days</span></span>'''</span>
  
| style="width: 83px; border-top: none; border-left: none; border-bottom: 1pt solid windowtext; border-right: 1pt solid windowtext;" width="73" | <p align="center" style="text-align:center; padding:0cm 5.4pt 0cm 5.4pt"><span style="height:15.5pt"><span style="font-size:11.0pt"><span style="font-family:" times="" new="" roman",serif"="">29.4</span></span></span></p>  
+
| style="width: 83px; border-top: none; border-left: none; border-bottom: 1pt solid windowtext; border-right: 1pt solid windowtext;" width="73" | <p align="center" style="text-align:center; padding:0cm 5.4pt 0cm 5.4pt"><span style="height:15.5pt"><span style="font-size:11.0pt"><span style="font-family:">29.4</span></span></span></p>  
| style="width: 58px; border-top: none; border-left: none; border-bottom: 1pt solid windowtext; border-right: 1pt solid windowtext;" width="42" | <p align="center" style="text-align:center; padding:0cm 5.4pt 0cm 5.4pt"><span style="height:15.5pt"><span style="font-size:11.0pt"><span style="font-family:" times="" new="" roman",serif"="">11.3</span></span></span></p>  
+
| style="width: 58px; border-top: none; border-left: none; border-bottom: 1pt solid windowtext; border-right: 1pt solid windowtext;" width="42" | <p align="center" style="text-align:center; padding:0cm 5.4pt 0cm 5.4pt"><span style="height:15.5pt"><span style="font-size:11.0pt"><span style="font-family:">11.3</span></span></span></p>  
| style="width: 109px; border-top: none; border-left: none; border-bottom: 1pt solid windowtext; border-right: 1pt solid windowtext;" width="66" | <p align="center" style="text-align:center; padding:0cm 5.4pt 0cm 5.4pt"><span style="height:15.5pt"><span style="font-size:11.0pt"><span style="font-family:" times="" new="" roman",serif"="">17.8</span></span></span></p>  
+
| style="width: 109px; border-top: none; border-left: none; border-bottom: 1pt solid windowtext; border-right: 1pt solid windowtext;" width="66" | <p align="center" style="text-align:center; padding:0cm 5.4pt 0cm 5.4pt"><span style="height:15.5pt"><span style="font-size:11.0pt"><span style="font-family:">17.8</span></span></span></p>  
| style="width: 44px; border-top: none; border-left: none; border-bottom: 1pt solid windowtext; border-right: 1pt solid windowtext;" width="45" | <p align="center" style="text-align:center; padding:0cm 5.4pt 0cm 5.4pt"><span style="height:15.5pt"><span style="font-size:11.0pt"><span style="font-family:" times="" new="" roman",serif"="">13.6</span></span></span></p>  
+
| style="width: 44px; border-top: none; border-left: none; border-bottom: 1pt solid windowtext; border-right: 1pt solid windowtext;" width="45" | <p align="center" style="text-align:center; padding:0cm 5.4pt 0cm 5.4pt"><span style="height:15.5pt"><span style="font-size:11.0pt"><span style="font-family:">13.6</span></span></span></p>  
| style="width: 80px; border-top: none; border-left: none; border-bottom: 1pt solid windowtext; border-right: 1pt solid windowtext;" width="84" | <p align="center" style="text-align:center; padding:0cm 5.4pt 0cm 5.4pt"><span style="height:15.5pt"><span style="font-size:11.0pt"><span style="font-family:" times="" new="" roman",serif"="">59.0</span></span></span></p>  
+
| style="width: 80px; border-top: none; border-left: none; border-bottom: 1pt solid windowtext; border-right: 1pt solid windowtext;" width="84" | <p align="center" style="text-align:center; padding:0cm 5.4pt 0cm 5.4pt"><span style="height:15.5pt"><span style="font-size:11.0pt"><span style="font-family:">59.0</span></span></span></p>  
| style="width: 90px; border-top: none; border-left: none; border-bottom: 1pt solid windowtext; border-right: 1pt solid windowtext;" width="84" | <p align="center" style="text-align:center; padding:0cm 5.4pt 0cm 5.4pt"><span style="height:15.5pt"><span style="font-size:11.0pt"><span style="font-family:" times="" new="" roman",serif"="">-404 to 522</span></span></span></p>  
+
| style="width: 90px; border-top: none; border-left: none; border-bottom: 1pt solid windowtext; border-right: 1pt solid windowtext;" width="84" | <p align="center" style="text-align:center; padding:0cm 5.4pt 0cm 5.4pt"><span style="height:15.5pt"><span style="font-size:11.0pt"><span style="font-family:">-404 to 522</span></span></span></p>  
 
|}
 
|}
  
'''<span style="font-family:" times="" new="" roman",serif"="">Comments:</span>'''
+
'''<span style="font-family:">Comments:</span>'''
  
#<span style="font-family:" times="" new="" roman",serif"="">Small study with no sample size calculation described.</span>  
+
#<span style="font-family:">Small study with no sample size calculation described.</span>  
#<span style="font-family:" times="" new="" roman",serif"="">The hypothesis is that HBOT activates the stem cells that have been injected into the pancreatic artery, thus stimulating growth of islet cells (based on rodent model).</span>  
+
#<span style="font-family:">The hypothesis is that HBOT activates the stem cells that have been injected into the pancreatic artery, thus stimulating growth of islet cells (based on rodent model).</span>  
#<span style="font-family:" times="" new="" roman",serif"="">There was no assessment of hyperbaric treatment or autologous stem cell transplant alone. It is unclear how much of the improvement can be attributed to hyperbaric versus stem cell transplant.</span>  
+
#<span style="font-family:">There was no assessment of hyperbaric treatment or autologous stem cell transplant alone. It is unclear how much of the improvement can be attributed to hyperbaric versus stem cell transplant.</span>  
#<span style="font-family:" times="" new="" roman",serif"="">The authors extravagantly claim the techniques used are safe based upon 13 cases.</span>  
+
#<span style="font-family:">The authors extravagantly claim the techniques used are safe based upon 13 cases.</span>  
#<span style="font-family:" times="" new="" roman",serif"="">The idea is to overcome the lack of donors for transplantation and the complications following transplant.</span>  
+
#<span style="font-family:">The idea is to overcome the lack of donors for transplantation and the complications following transplant.</span>  
  
'''<span style="font-family:" times="" new="" roman",serif"="">Appraised by:</span>'''<span style="font-family:" times="" new="" roman",serif"="">Hannah Rubinstein h.rubinstein@student.unsw.edu.au; Tuesday, 14 December 2021</span>
+
'''<span style="font-family:">Appraised by:</span>'''<span style="font-family:">Hannah Rubinstein h.rubinstein@student.unsw.edu.au; Tuesday, 14 December 2021</span>
  
'''<span style="font-family:" times="" new="" roman",serif"="">Kill or Update By:</span>'''<span style="font-family:" times="" new="" roman",serif"="">November 2023</span>
+
'''<span style="font-family:">Kill or Update By:</span>'''<span style="font-family:">November 2023</span>
 +
<p style="text-align: center;">&nbsp;</p> <p style="text-align: center;">[[File:Sumhorsa.gif|center|Sumhorsa.gif]]</p> <p style="text-align: center;"><span style="font-size:xx-large;">[http://hboevidence.wikis.unsw.edu.au/Miscellaneous BACK]</span></p>

Latest revision as of 02:57, 12 January 2022

Hyperbaric oxygen in combination with autologous bone marrow stem cell transplant improved HbA1c, pancreatic function and reduced insulin requirements in type 2 diabetic patients.

 

Clinical bottom line:

  1. HBO in combination with stem cell transplant improved HBA1c, glucose and C-peptide levels and reduced insulin requirements

Citation/s:1. Estrada EJ, Decima JL, Bortman G, Roberti J, Romero EB, Samaja G, Saavedra AR, Martinez G, Gutierrez S. Combination treatment of autologous bone marrow stem cell transplantation and hyperbaric oxygen therapy for type 2 diabetes mellitus: A randomised controlled trial. Cell Transplantation. 2019, 28(12), 1632-1640.


Lead author’s name and fax:J. Roberti : javierroberti@gmail.com

Three-part Clinical Question:In type 2 diabetic patients, does hyperbaric oxygen in combination with intrapancreatic autologous stem cell transplantation result in improved metabolic control as compared to standard pharmacological therapy alone?

Search Terms:Type 2 diabetes; stem cell therapy; autologous transplantation

 

The Study:Non-blinded non-concealed randomised controlled trial with intention-to-treat.

The Study Patients:Adult type 2 diabetic patients who had been previously treated with a medical therapy regimen including insulin. Patients with a BMI >35, insulin requirement >100 U/day, HbA1c >9.5% or glutamate decarboxylase seropositivity were excluded from the study.

Control group(N = 10; 10 analysed): Anti-hyperglycaemic therapy as per endocrinologist advice in line with American Diabetes Association Guidelines as well as statin therapy and aspirin unless contraindicated.

Experimental group(N = 13; 13 analysed): Anti-hyperglycaemic, statin and aspirin therapy as in the control group, HBOT 100% O2 at 2.5 ATA for 10 sessions over 3 weeks, and intra-arterial pancreatic autologous stem cell infusion.

The Evidence:

Outcome

Time to Outcome

Control group

HBO and stem cell group

Relative Risk Reduction

Absolute Risk Reduction

NNT

HbA1c reduction at least 1% (180 days)

180 days

0.3

0.77

156%

0.47

2

95% CI:

35% to 278%

0.1 to 0.8

1 to 10

 

Measure

Control Group

HBOT and stem cell  Group

Difference

95% CI

Mean

SD

Mean

SD

HbA1c (%) at 365 days

8.0

0.7

7.3

0.9

0.7

0.1 to 1.3

Glucose (mmol/L) at 90 days

9.9

1.0

6.7

1.5

3.2

1.7 to 4.7

C-peptide (ng/ml)

0.7

0.4

1.9

1.0

1.2

0.6 to 1.8

Insulin requirement (u/24hrs) 180 days

29.4

11.3

17.8

13.6

59.0

-404 to 522

Comments:

  1. Small study with no sample size calculation described.
  2. The hypothesis is that HBOT activates the stem cells that have been injected into the pancreatic artery, thus stimulating growth of islet cells (based on rodent model).
  3. There was no assessment of hyperbaric treatment or autologous stem cell transplant alone. It is unclear how much of the improvement can be attributed to hyperbaric versus stem cell transplant.
  4. The authors extravagantly claim the techniques used are safe based upon 13 cases.
  5. The idea is to overcome the lack of donors for transplantation and the complications following transplant.

Appraised by:Hannah Rubinstein h.rubinstein@student.unsw.edu.au; Tuesday, 14 December 2021

Kill or Update By:November 2023

 

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