Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03056664
Recruitment Status : Unknown
Verified September 2016 by Sixth Affiliated Hospital, Sun Yat-sen University.
Recruitment status was:  Not yet recruiting
First Posted : February 17, 2017
Last Update Posted : February 17, 2017
Sponsor:
Information provided by (Responsible Party):
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.

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.

Layout table for study information
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

Resource links provided by the National Library of Medicine


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




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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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.

Layout table for additonal information
Responsible Party: Sixth Affiliated Hospital, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03056664    
Other Study ID Numbers: MSCINCDGL
First Posted: February 17, 2017    Key Record Dates
Last Update Posted: February 17, 2017
Last Verified: September 2016
Additional relevant MeSH terms:
Layout table for MeSH terms
Crohn Disease
Fistula
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Pathological Conditions, Anatomical