Human Umbilical-Cord-Derived Mesenchymal Stem Cell Therapy in Active Ulcerative Colitis

Ulcerative Colitis Clinical Trial

— UCMSC-UC  

Official title:

Safety and Efficacy of Human Umbilical-Cord-derived Mesenchymal Stem Cell Transplantation in Active Ulcerative Colitis.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02442037
• Other study ID #: 307-IVY-SC-002
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: May 6, 2015
• Last updated: May 14, 2015
• Start date: May 2015
• Est. completion date: December 2017

Study information

• Verified date: May 2015
• Source: Affiliated Hospital to Academy of Military Medical Sciences
• Contact: Yan Liu, M.D.
• Phone: +86-010-66947473
• Email: 13911798288[@]163.com
• Is FDA regulated: No
• Health authority: China: National Health and Family Planning Commission
• Study type: Interventional

Clinical Trial Summary

Phase I-II Clinical Trial - Safety and efficacy of umbilical-cord-derived mesenchymal stem cell (UC-MSC) in patients with active ulcerative colitis，randomized, single blind, controlled prospective study.

Description:

Phase I-II Clinical Trial - Safety and efficacy of umbilical-cord-derived mesenchymal stem cell (UC-MSC) in patients with active ulcerative colitis，randomized, single blind, controlled prospective study.

Thirty patients will be selected and randomized into two groups: the first group of 15 patients will receive a sole injection of UC-MSC and the remaining 15 patients will comprise the control group.

Every patient will maintain their standard treatment of active ulcerative colitis, with maximum tolerated dosage without side effects.

The day of infusion will be considered day zero. From that moment, followup will be divided into 0-1 week, 1 week-2 week,2 week-3 week, 3 week-1 month, and 3 month-6 months.

Clinical results will be analyzed after completion of 6 months of followup.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• The diagnosis of active UC must have been confirmed by endoscopic and histological evidence.

• With mild and moderate disease.

• Men and women 18-65 years of age.

• Signed informed consent

• Capable of good communication with researchers and follow the entire test requirements

Exclusion Criteria:

• Patient with associated diseases such as diabetes mellitus, hypertension, dyslipidemia, atherosclerosis and malabsorption syndrome.

• With autoimmune diseases (lupus, HIV, cancer and hepatitis), colitis (infectious, post-radiation, post-drug, indeterminate) and Crohn's Disease.

• Abnormal hepatic or renal function

• Prior history of malignancy

• Pregnant or unwilling to practice contraceptive therapy or breast feeding females

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Biological:
• UCMSC group
Human umbilical cord MSCs are transplanted three times by intravenous infusion(1×10^6/kg) ,once every week,a total of three times.

Other:
• Control group(Normal saline)
Normal saline in same volume as MSCs are transplanted to patients.

Locations

Country	Name	City	State
China	Department of gastroenterology,Affiliated Hospital to Academy of Military Medical Sciences	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Affiliated Hospital to Academy of Military Medical Sciences	Ivy Institute of Stem Cells Co. Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety will be determined by the assessment of major adverse events.	Safety will be determined by the assessment of major adverse events defined as fever, allergy or any other intravenous infusion adverse events.	Within the six months after intravenous infusion	Yes
Secondary	Clinical response (CDAI points)	CDAI is defined as Clinical Disease Activity Index.	Post first cell transplantation: 3 weeks and months 1,3 and 6	No
Secondary	Endoscopic improvement is assessed by UCEIS.	UCEIS is defined as Ulcerative Colitis Endoscopic Index of Severity.	Post first cell transplantation 6 months	No
Secondary	Level of C-reactive protein		Post first cell transplantation: 3 weeks and months 1,3 and 6	No