Table 2.
Summary of the major clinical trials utilizing MSCs as a treatment for T1D
(clinicaltrials.gov)
| Number | Trial number | Status | Phase | N (patients), age (years) | Cell type, mode of administration and dose | Results | Reference |
|---|---|---|---|---|---|---|---|
| 1 | NCT01068951 | Completed in 2013 | N/A | N = 20, Age = 18–40 | Fresh autologous BM-MSCs given through Intravenous infusion, (approximately 2 × 106 cells/kg body weight) | Patients in the control arm showed losses in both C-peptide peak values and C-peptide during the first year. In MSC-treated patients, these responses were preserved or even increased. No side effects of MSC treatment were observed | [77] |
| 2 | NCT01374854 | Completed in 2012 | 1/2, randomized | N = 42, Age = 18–65 | 1 × 106/kg UC-MSCs infused and 106.8 × 106/kg BM-MNCs through the pancreatic artery along with by interventional therapy | C-peptide increased 105.7% in 20 of 21 responders versus 7.7% decrease in control subjects. HbA1C decreased 12.6% in treated versus 1.2% increase in control group. Fasting glycemia decrease 24.4% in treated versus 4.3% in control subjects. Daily insulin requirements decreased 29.2% in treated versus no change in control group | [78] |
| 3 | NCT01219465 | Completed in 2012 | 1/2, non-randomized | N = 29, Age: 03–35 | Fresh human UC-MSCs through Intravenous infusion, (2 × 107 cells/kg body weight) | MSC-treated was found to be safe. HbA1c was found to be lower and C-peptide was found to be higher in MSC-treated patients as compared to saline-treated patients during follow up | [79] |
| 4 |
Recruiting Unknown |
1/2 | N = 20 | Cord blood-derived multipotent cells will be modified within the Stem Cell Educator device | A single treatment provided lasting reversal of autoimmunity that allowed regeneration of islet β cells and improvement of metabolic control in subjects with long-standing T1D | [80–82] | |
| 5 | NCT02057211 | Started in 2014, Suspended at present | 2 | N = 50 | Fresh Autologous MSCs, N/A | N/A | |
| 6 | NCT02644759 | Started in 2014, recruiting | 1/2 | N = 100 | Fresh autologous CD34+/CD133+ cells, Transplantation of autologous CD34+/CD133+ cells into the pancreatic artery and capillaries via interventional radiology techniques. Immunomodulation by incubation of autologous UC-MSCs for 3–6 h, and return of autologous WBCs back via intravenous injection | N/A |