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

Primary Purpose

Crohn's Disease, Fistula

Status

Unknown status

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Routine drainage surgery

MSC injection 01

MSC injection 02

placebo

About this trial

This is an interventional treatment trial for Crohn's Disease

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age 18-65 years old, male or female;
refractory CD fistula, there are 1-2 and 1-3 in the mouth fistula;
Diagnostic CD at least three months;
CDAI <250;
were receiving drug treatment (5-ASA and hormones> 4 weeks, immunosuppressants and biological agents> 8 weeks);
signed informed consent.

Exclusion Criteria:

with intestinal obstruction, stenosis, or perianal abscess;
pregnant or lactating women;
infection needs antibiotics persons;
rectovaginal fistula;
complex anal fistula more than two inside the mouth;
stenosis or perforation CD;
perianal infection;
could not do rectal or anal stenosis local injection therapy;
with acute enteritis;
, liver and kidney dysfunction;
a month have used other drugs are in clinical trials;
no conditions or unwilling to carry out MRI inspected;
who are adjusting therapy;
HIV patients;
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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

MSC-1

MSC-2

Ctrl

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Clinical response(fistula closure)

Physical examination indicates fistula healing, or MRI examinations showed fistula healing more than 2cm

Secondary Outcome Measures

C-reactive protein (CRP)

To summarize the changes from baseline compared to 12 weeks in serum C-reactive protein (CRP)

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)

Full Information

NCT ID

NCT03056664

First Posted

August 24, 2015

Last Updated

February 14, 2017

Sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

1. Study Identification

Unique Protocol Identification Number

NCT03056664

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2016

Overall Recruitment Status

Unknown status

Study Start Date

January 2017 (undefined)

Primary Completion Date

December 2019 (Anticipated)

Study Completion Date

December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Crohn's Disease, Fistula

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

3 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

MSC-1

Arm Type

Experimental

Arm Description

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

Arm Title

MSC-2

Arm Type

Experimental

Arm Description

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

Arm Title

Ctrl

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Routine drainage surgery

Intervention Type

Biological

Intervention Name(s)

MSC injection 01

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

MSC injection 02

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

placebo

Intervention Description

NS injection instead of MSC

Primary Outcome Measure Information:

Title

Clinical response(fistula closure)

Description

Physical examination indicates fistula healing, or MRI examinations showed fistula healing more than 2cm

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

C-reactive protein (CRP)

Description

To summarize the changes from baseline compared to 12 weeks in serum C-reactive protein (CRP)

Time Frame

12 weeks

Title

Clinical Response

Description

Time Frame

6 weeks after receiving treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age 18-65 years old, male or female; refractory CD fistula, there are 1-2 and 1-3 in the mouth fistula; Diagnostic CD at least three months; CDAI <250; were receiving drug treatment (5-ASA and hormones> 4 weeks, immunosuppressants and biological agents> 8 weeks); signed informed consent. Exclusion Criteria: with intestinal obstruction, stenosis, or perianal abscess; pregnant or lactating women; infection needs antibiotics persons; rectovaginal fistula; complex anal fistula more than two inside the mouth; stenosis or perforation CD; perianal infection; could not do rectal or anal stenosis local injection therapy; with acute enteritis; , liver and kidney dysfunction; a month have used other drugs are in clinical trials; no conditions or unwilling to carry out MRI inspected; who are adjusting therapy; HIV patients; 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.

12. IPD Sharing Statement

Learn more about this trial

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

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