1. Data Extracted from the included studies:
Study name | Garcia‐Olmo 2009 | Molendijk 2015 | Melmed 2015 | Panes 2016 | Zhang 2018 | Hawkey 2015 | Zhou 2020 | |
CCC of patients | Age | In ALL study 43.33, SD 9.9 I: mean 42.64, SD 10.93 P: 43.99, SD 8.97 |
Mean age: 38 Group 1: Mean: 40.4 (27‐54) Group 2: Mean: 40.8 (37‐47) Group 3: Mean: 33.4 (21‐48) Placebo: Mean: 37.3 (27‐49) | 1 unit: mean 35.3 SD 14 4 units: mean 36.2 SD 11.6 Placebo: mean 36.5 SD7.3 |
I: mean 39.0 (13.1) P: mean 37.6 (13.1) |
>18y‐70 years I:34.3 (21‐44) P: 32.7(20‐41) |
I: Median: 34.1 IQR: (26.1‐41.2) P: Median: 30.6 IQR:(24.0‐37.6) | Range from; 12‐51 28.86 ± 10.13 I: 24.4 ± 5.0 C: 24.9 ± 5.4 |
sex | In all study 24/25 M/F I: 10/14 P: 14/11 |
Male in 4 groups: 4/5 4/5 1/5 3/6 M/F: 12/9 |
1 unit:53.3% M/F:8/7 4 units:33.3 % 5/10 placebo:43.8% 7/9 |
I: 60/47 P: 56/49 |
I: 24/17 P: 26/15 |
Women: I: 13/23 P: 11/22 |
1 female 21 male (M/F) Intervention: 11/0 Control: 10/1 |
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Disease duration in years | Not mentioned | In years in 4 groups I: 7.6 (5‐11) II: 16.8 (5‐28) III: 13.2 (2‐23) Placebo: 6.8 (1‐20) |
Mean I unit:18.5 yrs SD 13.8 4 units:10.4 yrs SD 10.7 placebo: 16.2 yrs SD9.4 |
I: 12.1 (10.0) P: 11.3 (8.9) years |
I: 7 (2‐15) C: 8 (3‐14) | I: 14.9 y P: 11.2 y |
Not mentioned | |
Disease location | Rectovaginal fistula = 8/49 I= 4, P= 4 Suprasphincteric fistulous tract= 30/49 I= 14, P= 16 | Perianal Group 1: L1= 1, L2 =3, L3=1 Group 2: L1= 1, L2=2,L3= 2 Group 3: L1=2,L2=1,L3=2 Placebo: L1=1,L2=2,L3=2, L3+L4=1 |
Perianal High inter‐sphincteric, trans‐sphincteric, extra‐sphincteric or supra‐sphincteric. (?) |
I/C Ileal: 14/17 Colonic:18/14 Ileocolonic:9/10 Isolated upper:6/9 |
Intervention:
Ileum (L1) 1 (9.1%) Colon (L2) 4 (36.4%) Ileocolon (L3) 6 (54.6%) Upper GI (L4) 0 (0.0%) Control: Ileum (L1): 1 (9.1%) Colon (L2): 3 (27.3%) Ileocolon (L3): 7 (63.6%) Upper GI (L4) 0 (0.0%) |
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Previous and concomitant medications | at least one complete course of antibiotics with a seton placement or conventional surgery (advancement flap or fistulectomy), at least one complete induction course of infliximab, unless anti‐TNF‐α treatment was contraindicated Concomitant: any except infliximab, tacrolimus, or cyclosporine |
Mesalamine, steroids, anti TNF, immunosuppressives | Aminosalicylates‐corticosteroids‐immunomodulators‐biologics (at least 3m before study) | concomitant but refractory to immunomodulatory and anti‐TNF and antibiotics at randomisation | Steroids for the last 6 months and as background treatment Anticoagulation prior to treatment (2,500 IU of low‐molecular‐weight heparin ) |
I/P Prior drugs: Azathioprine/6MP:22/22 Methotrexate:19/18 Anti TNF:23/22 Other:10/9 |
During the study, all patients received aminosalicylic acid (Mesalazine) and probiotic treatment. One patient in the observation group and three patients in the control group received immunomodulator treatment. One patient in each group was given antibiotics. |
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Previous bowel surgeries | Yes (adv flap or fistulectomy) Previous fistula surgery: 39/49 I= 17, P= 22 |
None | None | None | I:12 P:9 |
I: 2/23 P: 2/22 Ileostomy: I: 4/23 P: 4/22 |
Not mentioned | |
Funding | This clinical trial has been sponsored by Cellerix S.L. | This work was supported by the DigestScience Foundation. | the study is funded by Celularity Incorporated | The study was funded by TiGenix | none mentioned | This study was sponsored by the European Group for Blood and Marrow Transplantation (EBMT) Autoimmune Diseases Working Party and the European Crohn and Colitis Organisation (ECCO). | This work was funded by Key Medical Science and Technology Development |
Data here are not mentioned in the characteristics of the studies.