Table 4: Ongoing clinical trials using cells for
treatment of anal fistula (Part 2). An update of the tables taken from the
section “Stem Cell Application in Fistula Disease”. [33] ASCs: adult stem
cells. Source: Clinicaltrials.gov
Trial code |
Cell Source |
Expanded |
Cells number |
Status |
Phase |
Intervention model |
Masking |
Estimated enrollment |
NCT00999115 |
Allogeneic fat |
Yes |
2 ×10e7, when no
effect 4 ×10e7 |
Completed.
Publications not provided |
1.2 |
Single arm |
Open label |
10 |
NCT01541579 |
Allogeneic fat |
Yes |
12 × 10e7 |
Ongoing, not recruiting |
3 |
Two arms: (ASCs,
placebo) |
Double blind |
208 |
NCT00482092 |
Allogeneic bone marrow |
Yes |
120 × 10e7 or 60 × 10e7
cells infused in four visits |
Ongoing, not
recruiting |
3 |
Three arms: Placebo,
high dose and low dose |
Double blind |
270 |
NCT01803347 |
Autologous fat |
Yes |
10 × 10e7, additional
dose when no effect |
Recruiting |
3 |
Two arms: ASCs +
fibrin glue, fibrin glue |
Double blind |
80 |
NCT02403232 |
Autologous fat |
No |
Not specified |
Recruiting |
2 |
Single arm ASCs +
infliximab |
Open label |
10 |
NCT01915927 |
Autologous fat |
Yes |
2 × 10e7 |
Recruiting |
1 |
Stem-cell-coated plug |
Open label |
20 |
NCT01874015 |
Autologous bone marrow |
Yes |
Dose not specified. 4
injections |
Recruiting |
1 |
Two arms: ASCs +
fibrin, ASCs + fibroblast + fibrin |
Single blind |
10 |
NCT02000362 |
Allogeneic umbilical
cord |
Yes |
5 × 10e7 or 1 × 10e8 |
Recruiting |
1.2 |
Two arms: low dose,
high dose |
Open label |
24 |
NCT02520843 |
Autologous fat |
No |
Not specified |
Recruiting |
1.2 |
Single arm |
Open label |
10 |
NCT02677350 |
Allogeneic bone marrow |
Yes |
2 × 10e7 divided in 10
inyections of 2 millon |
Recruiting |
1 |
Single arm |
Open label |
20 |