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

Phase 2

• Conditions: Fistula; Crohn's Disease
• Interventions: Procedure: Routine drainage surgery; Biological: MSC injection 01; Other: placebo; Biological: MSC injection 02

• Registration Number: NCT03056664
• Lead Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University

Brief 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.

Study Timeline

• Study First Submitted: 2015-08-24
• Status Verified: 2016-09
• Study Start: 2017-01
• Study First Submitted QC: 2017-02-14
• Last Update Submitted: 2017-02-14
• Study First Posted: 2017-02-17
• Last Update Posted: 2017-02-17
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

1. Age 18-65 years old, male or female;
2. refractory CD fistula, there are 1-2 and 1-3 in the mouth fistula;
3. Diagnostic CD at least three months;
4. CDAI <250;
5. were receiving drug treatment (5-ASA and hormones> 4 weeks, immunosuppressants and biological agents> 8 weeks);
6. signed informed consent.

Exclusion Criteria

1. with intestinal obstruction, stenosis, or perianal abscess;
2. pregnant or lactating women;
3. infection needs antibiotics persons;
4. rectovaginal fistula;
5. complex anal fistula more than two inside the mouth;
6. stenosis or perforation CD;
7. perianal infection;
8. could not do rectal or anal stenosis local injection therapy;
9. with acute enteritis;
10. , liver and kidney dysfunction;
11. a month have used other drugs are in clinical trials;
12. no conditions or unwilling to carry out MRI inspected;
13. who are adjusting therapy;
14. HIV patients;
15. The combined active hepatitis or tuberculosis; Occurred in 16) 6 months opportunistic infections, or severe infections occur within three months;

17. In the past five years, those who suffer from cancer; 18) there is a history of lymphoproliferative disease.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MSC-1	MSC injection 01	Patient in this arm will receive routine surgery and local MSC injection of 3×10E6/kg
Ctrl	placebo	Patient in this arm will receive routine surgery and local NS injection
MSC-1	Routine drainage surgery	Patient in this arm will receive routine surgery and local MSC injection of 3×10E6/kg
MSC-2	Routine drainage surgery	Patient in this arm will receive routine surgery and local MSC injection of 6×10E6/kg
MSC-2	MSC injection 02	Patient in this arm will receive routine surgery and local MSC injection of 6×10E6/kg
Ctrl	Routine drainage surgery	Patient in this arm will receive routine surgery and local NS injection

Primary Outcome Measures

Name	Time	Method
Clinical response(fistula closure)	12 weeks	Physical examination indicates fistula healing, or MRI examinations showed fistula healing more than 2cm

Secondary Outcome Measures

Name	Time	Method
Clinical Response	6 weeks after receiving treatment	CDAI means Crohn's Disease Activity Index.The purpose of this crohn's disease activity index (CDAI) calculator is to gauge the progress or lack of progress for people with crohn's disease. The reference article says "generally speaking, CDAI scores below 150 indicate a better prognosis than higher scores." Clinical Response of patients 6 weeks after receiving treatment (CDAI score less than 150)
C-reactive protein (CRP)	12 weeks	To summarize the changes from baseline compared to 12 weeks in serum C-reactive protein (CRP)