The Role of MSC in the Treatment of Fistulas in Patients With Perianal Crohn's Disease
NCT03056664 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 3
Last updated 2017-02-17
Summary
Here investigators will carry out this phase II clinical trial to explore a effective therapeutic regimen of MSC in the Crohn's perianal fistula.
Conditions
- Crohn's Disease
- Fistula
Interventions
- PROCEDURE
-
Routine drainage surgery
- BIOLOGICAL
-
MSC injection 01
Local MSC injection in peri-anal with a dose of 3×10E6/kg
- BIOLOGICAL
-
MSC injection 02
Local MSC injection in peri-anal with a dose of 6×10E6/kg
- OTHER
-
placebo
NS injection instead of MSC
Sponsors & Collaborators
-
Sixth Affiliated Hospital, Sun Yat-sen University
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-01-31
- Primary Completion
- 2019-12-31
- Completion
- 2019-12-31
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