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

Status

UNKNOWN

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03056664

Enrollment

Registered

2017-02-17

Start date

2017-01-31

Completion date

2019-12-31

Last updated

2017-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's Disease, Fistula

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.

Interventions

PROCEDURERoutine drainage surgery

BIOLOGICALMSC injection 01

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

BIOLOGICALMSC injection 02

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

OTHERplacebo

NS injection instead of MSC

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026