The Efficiency of MSC in Refractory Crohn's Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 7 September 2015
• Main ID: NCT02532738
• Date of registration: 23/08/2015
• Prospective Registration: Yes
• Primary sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
• Public title: The Efficiency of MSC in Refractory Crohn's Disease
• Scientific title: A Stage II Clinical Trial Comparing the Efficiacy of Routine Treatment Combined With or Without MSC Therapy in Refractory Crohn's Disease
• Date of first enrolment: January 2016
• Target sample size: 3
• Recruitment status: Not yet recruiting
• URL: https://clinicaltrials.gov/show/NCT02532738
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2/Phase 3

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Crohn's Disease

Intervention(s)

Biological: MSC treatment 01

Biological: MSC treatment 02

Other: NS

Drug: Routine Treatment of CD

Primary Outcome(s)

Clinical Response of CD patients 12 weeks after receiving treatment (Reduction of CDAI score at less 100) [Time Frame: 12 weeks after receiving treatment]

Secondary Outcome(s)

Clinical Response of CD patients 6 weeks after receiving treatment (CDAI score less than 150) [Time Frame: 6 weeks after receiving treatment]

Secondary ID(s)

MSCINRCD

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Third Affiliated Hospital, Sun Yat-Sen University

Nanfang Hospital of Southern Medical University