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

Crohn's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03056664
• Other study ID #: MSCINCDGL
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• First received: August 24, 2015
• Last updated: February 14, 2017
• Start date: January 2017
• Est. completion date: December 2019

Study information

• Verified date: September 2016
• Source: Sixth Affiliated Hospital, Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 3
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease
• Fistula

Intervention

Procedure:
• Routine drainage surgery

Biological:
• MSC injection 01
Local MSC injection in peri-anal with a dose of 3×10E6/kg
• MSC injection 02
Local MSC injection in peri-anal with a dose of 6×10E6/kg

Other:
• placebo
NS injection instead of MSC

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sixth Affiliated Hospital, Sun Yat-sen University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical response(fistula closure)	Physical examination indicates fistula healing, or MRI examinations showed fistula healing more than 2cm	12 weeks
Secondary	C-reactive protein (CRP)	To summarize the changes from baseline compared to 12 weeks in serum C-reactive protein (CRP)	12 weeks
Secondary	Clinical Response	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)	6 weeks after receiving treatment