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

• ClinicalTrials.gov Identifier: NCT03056664
• Recruitment Status: Unknown
• First Posted: February 17, 2017
• Last Update Posted: February 17, 2017
• Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
• Information provided by (Responsible Party): Sixth Affiliated Hospital, Sun Yat-sen University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Crohn's Disease; Fistula	Procedure: Routine drainage surgery; Biological: MSC injection 01; Biological: MSC injection 02; Other: placebo	Phase 2; Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 3 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Safety and Efficiacy of Local MSC Injection in the Treatment of Fistulas in Patients With Perianal Crohn's Disease
• Study Start Date: January 2017
• Estimated Primary Completion Date: December 2019
• Estimated Study Completion Date: December 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: MSC-1; Patient in this arm will receive routine surgery and local MSC injection of 3×10E6/kg	Procedure: Routine drainage surgery; Biological: MSC injection 01; Local MSC injection in peri-anal with a dose of 3×10E6/kg
Experimental: MSC-2; Patient in this arm will receive routine surgery and local MSC injection of 6×10E6/kg	Procedure: Routine drainage surgery; Biological: MSC injection 02; Local MSC injection in peri-anal with a dose of 6×10E6/kg
Experimental: Ctrl; Patient in this arm will receive routine surgery and local NS injection	Procedure: Routine drainage surgery; Other: placebo; NS injection instead of MSC

Outcome Measures

Primary Outcome Measures :

1. Clinical response(fistula closure) [ Time Frame: 12 weeks ]
   Physical examination indicates fistula healing, or MRI examinations showed fistula healing more than 2cm

Secondary Outcome Measures :

1. C-reactive protein (CRP) [ Time Frame: 12 weeks ]
   To summarize the changes from baseline compared to 12 weeks in serum C-reactive protein (CRP)
2. Clinical Response [ Time Frame: 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)

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: Sixth Affiliated Hospital, Sun Yat-sen University
• ClinicalTrials.gov Identifier: NCT03056664
• Other Study ID Numbers: MSCINCDGL
• First Posted: February 17, 2017
• Last Update Posted: February 17, 2017
• Last Verified: September 2016

Additional relevant MeSH terms:

Crohn Disease; Fistula; Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Pathological Conditions, Anatomical