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

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 Overview

• Status: Unknown
• Conditions: Fistula; Crohn's Disease
• Intervention / Treatment: Procedure: Routine drainage surgery; Biological: MSC injection 01; Biological: MSC injection 02; Other: placebo

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 Type: Interventional
• Enrollment (Anticipated): 3
• Phase: Phase 2; Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical response(fistula closure)	Physical examination indicates fistula healing, or MRI examinations showed fistula healing more than 2cm	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
C-reactive protein (CRP)	To summarize the changes from baseline compared to 12 weeks in serum C-reactive protein (CRP)	12 weeks
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

Collaborators and Investigators

• Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start: January 1, 2017
• Primary Completion (ANTICIPATED): December 1, 2019
• Study Completion (ANTICIPATED): December 1, 2019

Study Registration Dates

• First Submitted: August 24, 2015
• First Submitted That Met QC Criteria: February 14, 2017
• First Posted (ACTUAL): February 17, 2017

Study Record Updates

• Last Update Posted (ACTUAL): February 17, 2017
• Last Update Submitted That Met QC Criteria: February 14, 2017
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Pathological Conditions, Anatomical; Inflammatory Bowel Diseases; Fistula; Crohn Disease
• Other Study ID Numbers: MSCINCDGL