Estrada
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:
- 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:
- Small study with no sample size calculation described.
- 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).
- 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.
- The authors extravagantly claim the techniques used are safe based upon 13 cases.
- 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