NCT03056664

The Role of MSC in the Treatment of Fistulas in Patients With Perianal Crohn's Disease

The Safety and Efficiacy of Local MSC Injection in the Treatment of Fistulas in Patients With Perianal Crohn's Disease

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 3 (estimated)
• Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Peri-anal fistula is common seen in Crohn's disease. Treatments including surgery, antibiotics, immunosuppressive drug and infliximab improve the quality of life of the patients suffering Crohn's perianal fistula, but the recurrent rate is still high. MSC showed promising effect in the therapy of CD, but the standard treatment strategy is unclear. 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

Type	Name	Description
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

Timeline

• Start date: 2017-01-01
• Primary completion: 2019-12-01
• Completion: 2019-12-01
• First posted: 2017-02-17
• Last updated: 2017-02-17