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