Human Umbilical-Cord-Derived Mesenchymal Stem Cell Therapy in Active Ulcerative Colitis (UCMSC-UC)

Affiliated Hospital to Academy of Military Medical Sciences

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Ulcerative Colitis

Treatments: Other: Control group(Normal saline); Biological: UCMSC group

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02442037

307-IVY-SC-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

UCMSC group

Experimental group

Description:

Human umbilical cord MSCs are administrated to patients by three intravenous infusion

Treatment:

Biological: UCMSC group

Control group(Normal saline)

Other group

Description:

Patients will receive normal saline at the same time points as that in experimental group.

Treatment:

Other: Control group(Normal saline)