Clinical trial no. | Cell type and source | Intervention | |
---|---|---|---|
Experimental group (fixed cell dose) | Control group | ||
(a) | |||
1 | ASCs autologous | First: 2 × 107 + fibrin glue | First: fibrin glue |
Second: double dose | Second: double dose | ||
2 | ASCs autologous | First: 2 × 107, 2 × 107 + fibrin glue | First: fibrin glue |
Second: double dose | Second: double dose | ||
3 | BSCs allogenic | Group 1: 1 × 107 | Saline solution (2.5–5 ml) |
Group 2: 3 × 107 | |||
Group 3: 9 × 107 | |||
4 | ASCs allogenic | 12 × 107 | Saline solution: 24 ml |
5 | ASCs autologous | First: 10 × 107 + fibrin glue | First: Fibrin glue (2–5 ml) |
Second: 10 × 107 + fibrin glue | Second: Fibrin glue (2–5 ml) | ||
6 | ASCs autologous | (142.3 ± 45.7) × 106 | Surgery |
Outcome assessment | Results (healed) | |||
---|---|---|---|---|
 ≤ 3 months |  > 3 months, ≤ 6 months | 1 year (48 ~ 52 weeks) |  > 1 year | |
(b) | ||||
Reepithelialisation; Reepithelialisation + MRI | 17/24 vs. 3/25 | / | 15/24 vs. 3/25 | 7/21 vs. 2/13 |
Reepithelialisation + MRI | 17/64, 23/60 vs. 9/59 | 25/64, 26/60 vs. 22/59 | 24/42, 22/42 vs. 19/51 | / |
Reepithelialisation + MRI | 2/5, 4/5, 1/5 vs. 2/6 | 4/5, 4/5, 1/5 vs. 2/6 | / | 3/4, 4/4, 1/5 vs. 0/3 |
Reepithelialisation + MRI | / | 53/103 vs. 36/101 | 58/103 vs. 39/101 | 14/25 vs. 6/15 |
Reepithelialisation + MRI | / | 7/23 vs. 9/21 | 11/20 vs. 12/19 | 10/20 vs. 5/19 |
Reepithelialisation + MRI/ERUS | 10/11 vs. 5/11 | 8/11 vs. 6/11 | 7/11 vs. 6/11 | / |