Title

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

    Phase 1/Phase 2
  • Study Type

    Interventional
  • Status

    Unknown status
  • Study Participants

    30
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.
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.
Study Started
May 31
2015
Primary Completion
May 31
2017
Anticipated
Study Completion
Dec 31
2017
Anticipated
Last Update
May 15
2015
Estimate

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.

UCMSC group Experimental

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

Control group(Normal saline) Other

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

Criteria

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
No Results Posted