Table 4 MSC-based therapy clinical studies in patients with T1D or T2D
Ref | Country | Study Type | MSC source | DM type | MSC-treated patient Size | Patients Age range (Y) Mean or range | BMI (kg/m2) | Duration of the disease (Y or M) Mean or range | Cell Dose and Frequency of Regimen | Allogenic vs. Autologous | Route Of Administration | Follow-up Duration (M) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
China | Pilot study | PL | T2D | 10 | 30–85 | ND | ≥ 3 Y | Three doses/one-month interval The total cell no. /pt with an average of 1.35 × 106 cells /kg | Allogenic | IV | 6 | |
China | RC, double-blinded | WJ | T1D | 15 | 17.6 ± 8.7 | 20.9 ± 3.7 | Newly onset, however, the exact duration was ND | Two doses (4 week-interval) Total mean cell number was 2.6 ± 1.2 × 107 | Allogeneic | IV | 24 | |
China | single-center prospective study | WJ | T2D | 22 | 52.9 ± 10.5 (18–70) | 25.1 ± 2.4 | 8.7 ± 4.3Y | Allogenic | Two doses (5-days interval) (1 × 106 cells/kg/dose) | IV & IP endovascular | 12 | |
Sweden | Single-center, RC, Open-label, pilot study | BM | T1D | 9 | Mean: 24 ± 2 (18–40) | 23.3 ± 1.1 | Diagnosed < 3weeks before enrollment | Autologous | 2.1–3.6 × 106 cells/kg (median 2.75 × 106 cells/kg) | IV | 12 | |
China | Pilot study | UC | T2D | 6 | 40.5± 3.76 | 23.7 ± 0.29 | 42.7± 13.02 M | Allogenic | 1 × 106 cells/kg BW (two doses with a two-week interval) | IV | 24–44 [33.2± 2.82] | |
China | RC, open-label | UC | T1D | 21 | 18–40 | 22.06 ± 2.46 | \(\:\ge\:\)2-\(\:\le\:\)16 | Allogenic MSCs and autologous BM-MNC | Single dose 1.1 × 106/kg UC-MSC & 106.8 × 106/kg aBM-MNC | DPA or its subsitute | 12 | |
China | RC, double-blinded | WJ | T2D | 31 | 52.43 ± 4.88 | 26.74 ± 5.41 | 8.93± 5.67 Y | Twice 4-weeks interval Mean cell number was 6.1± 2.1 × 107 | Allogenic | IV | 36 | |
China | cohort study | BM | T1D | 5 | 14–31 | 15.8–20.1 | 3.5–11 M | Allogenic | A single dose (1 × 106 cells/kg BW) | IV | 48 | |
India | RC | BMSC vs. BM-MNC | T2D | 19 | 30–60 | 28.1 | ≥ 5 years | Autologous | 1 × 106 cells/kg BW for aBMSCs 1 × 109 cells/patient aBM-MNC | SPD | 12 | |
Kazakh-stan | prospective cohort study | BM | T1D | 5 | 20–42 | ND | ND | Autologous | 95–97 × 106 | IV | 3 | |
Brazil | Prospective, RC, single-center, open trial, phase II, | AT | T1D | 8 | 16–35 | 20.76–26.06 | < 4 M | Allogenic | ASCs: 1 × 106 cells/kg BW (Single dose) & cholecalciferol 2000 UI/day for 3 months | IV | 3 | |
China | Pilot | Deciduous teeth | T2D | 22 | 55.96 ± 4.81 | 24.42 ± 2.64 | > 5Y | Allogenic | SHED: 1 × 106 cells/kg BW (Three doses at two week- interval | IV | 12 | |
Iran | R, non-C, open label phase 1 clinical trial | PL | T1D | 4 | 12–18 | 15.4–22 | < 6 M | Allogenic | ASCs: 1 × 106 cells/kg BW (single dose) | IV | 12 | |
Vietnam | R, non-C, open-label | BM | T2D | 30 | 55–66 | 40% <23 60% >23 | 46% ≤10 Y 54% >10 Y | Autologous | Single dose 1 × 106 cells/kg BW | IV (n = 15) or DPA (n = 15) | 6 (n = 29) 12(n = 25) | |
Iran | R, PC, double-blinded | BM | T1D | 11 | 10.27± 1.67 | 16.75 ± 2.57 | Early group received MSC therapy during the first year of diagnosis & late group received the treatment 1-year after diagnosis | Autologous | Two doses (1 × 106 cells/kg BW dose) Three week-interval | IV | 12 For each group | |
China | Pilot study | UC | T2D | 16 | 52.5 ± 7.91 | 24.47 ± 2.76 | 10.06 ± 5.74 Y | Allogeneic | Three doses (1 × 106 cells/kg BW dose) Once weekly | IV | ≈ 3 | |
China | A single-center, R, PC, double- blinded | UC | T2D | 45 | 50.00± 9.38 | 28.69 ± 3.35 | 11.44± 4.78 Y | Allogenic | Three doses with one- month interval (1 × 106/ Kg BW/ dose) | Elbow joint (IV) | 12 | |
China | RC, OPEN TRIAL | BM or UC | T1D | 14 BMSCs (n = 4) UC-MSCs (n = 10) | 15 (Median) | 17.3 ± 2.0 | 1 M (MEDIAN) | Allogenic | Single dose 1 × 106 cells/kg body | IV | 12 |