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

NCT ID: NCT03056664

Last Updated: 2017-02-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2019-12-31

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.

Conditions

Crohn's Disease; Fistula

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MSC-1

Patient in this arm will receive routine surgery and local MSC injection of 3×10E6/kg

Group Type: EXPERIMENTAL

Routine drainage surgery

Intervention Type: PROCEDURE

MSC injection 01

Intervention Type: BIOLOGICAL

Local MSC injection in peri-anal with a dose of 3×10E6/kg

MSC-2

Patient in this arm will receive routine surgery and local MSC injection of 6×10E6/kg

Group Type: EXPERIMENTAL

Routine drainage surgery

Intervention Type: PROCEDURE

MSC injection 02

Intervention Type: BIOLOGICAL

Local MSC injection in peri-anal with a dose of 6×10E6/kg

Ctrl

Patient in this arm will receive routine surgery and local NS injection

Group Type: EXPERIMENTAL

Routine drainage surgery

Intervention Type: PROCEDURE

placebo

Intervention Type: OTHER

NS injection instead of MSC

Interventions

Routine drainage surgery

Intervention Type: PROCEDURE

MSC injection 01

Local MSC injection in peri-anal with a dose of 3×10E6/kg

Intervention Type: BIOLOGICAL

MSC injection 02

Local MSC injection in peri-anal with a dose of 6×10E6/kg

Intervention Type: BIOLOGICAL

placebo

NS injection instead of MSC

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sixth Affiliated Hospital, Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

MSCINCDGL

Identifier Type: -

Identifier Source: org_study_id