Clinical trial NCT02442037: Human Umbilical-Cord-Derived Mesenchymal Stem Cell Therapy in Active Ulcerative Colitis
Official title: Safety and Efficacy of Human Umbilical-Cord-derived Mesenchymal Stem Cell Transplantation in Active Ulcerative Colitis.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Ulcerative Colitis
Keywords: cellular therapy
active ulcerative colitis
phase 1/2 clinical study
human umbilical cord mesenchymal stem cell
allogeneic stem cell transplantation
UC
Lead sponsor: Affiliated Hospital to Academy of Military Medical Sciences
Sponsor class: OTHER
Collaborators: name: Ivy Institute of Stem Cells Co. Ltd
First posted: 2015-05-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Safety will be determined by the assessment of major adverse events.
timeFrame: Within the six months after intravenous infusion
Secondary outcomes:
measure: Clinical response (CDAI points)
timeFrame: Post first cell transplantation: 3 weeks and months 1,3 and 6
measure: Endoscopic improvement is assessed by UCEIS.
timeFrame: Post first cell transplantation 6 months
measure: Level of C-reactive protein
timeFrame: Post first cell transplantation: 3 weeks and months 1,3 and 6
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of gastroenterology,Affiliated Hospital to Academy of Military Medical Sciences
Study officials:
affiliation: 307-IVY Translational Medicine Center
name: Bing Liu, M.D.
role: STUDY_CHAIR
affiliation: Department of gastroenterology,Affiliated Hospital to Academy of Military Medical Sciences
name: Yan Liu, M.D.
role: STUDY_DIRECTOR
affiliation: Department of gastroenterology,Affiliated Hospital to Academy of Military Medical Sciences
name: Min Min, M.D.
role: PRINCIPAL_INVESTIGATOR
References: