The Efficiency of MSC in Refractory Crohn's Disease

A Stage II Clinical Trial Comparing the Efficiacy of Routine Treatment Combined With or Without MSC Therapy in Refractory Crohn's Disease

Status

UNKNOWN

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02532738

Enrollment

Registered

2015-08-26

Start date

2016-01-31

Completion date

2018-12-31

Last updated

2015-08-26

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

Conditions

Crohn's Disease

Keywords

efficacy of MSC, refractory

Brief summary

The investigators' preliminary study indicates that MSC is effective therapy in treating IBD. But the standard treatment is still lacking and the effect is not stable in IBD patients. This study is to explore the efficacy and standard strategy when using MSC in refractory IBD.

Interventions

DRUGRoutine Treatment of CD

The Drug including 6MP, AZA, infliximab and thalidomide

BIOLOGICALMSC treatment 01

Injection of 3×10E6/kg of MSC

BIOLOGICALMSC treatment 02

Injection of 6×10E6/kg of MSC

OTHERNS

Injection of NS

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

* Failure or intolerance to GC, immune inhibitors and biological agents treatment * CDAI between 250-450 * Weight between 40-150 kg * Normal renal function * endoscopic or imaging diagnosis of CD in the small intestine, colon ileocolon * Signed informed consent

Exclusion criteria

* HIV or active hepatitis patients; * Allergic to CT contrast agents, cattle or pig products; * Stricture or perforation type CD; * Recieved permanent colostomy; * Used biological preparation in 3 months * Used prednisone \> 20 mg/day within 1 month ; * Patients with short bowel syndrome; * Need total parenteral nutrition; * Liver meritorious service is abnormal; * Suffering from malignant tumor during the last 5 years; * Combined bacterial or viral enteritis; * Suffering from intestinal typicality thickening of the living * Patients with tuberculosis.

Design outcomes

Primary

Measure	Time frame	Description
Clinical Response of CD patients 12 weeks after receiving treatment (Reduction of CDAI score at less 100)	12 weeks after receiving treatment	Reduction of CDAI score at less 100

Secondary

Measure	Time frame	Description
Clinical Response of CD patients 6 weeks after receiving treatment (CDAI score less than 150)	6 weeks after receiving treatment	CDAI score less than 150

Outcome results

None listed

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