NCT02442037

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started May 2015

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

May 6, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 13, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

May 15, 2015

Status Verified

May 1, 2015

Enrollment Period

2 years

First QC Date

May 6, 2015

Last Update Submit

May 14, 2015

Conditions

Ulcerative Colitis

Keywords

cellular therapyactive ulcerative colitisphase 1/2 clinical studyhuman umbilical cord mesenchymal stem cellallogeneic stem cell transplantationUC

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Clinical response (CDAI points)

    Post first cell transplantation: 3 weeks and months 1,3 and 6

  • Endoscopic improvement is assessed by UCEIS.

    Post first cell transplantation 6 months

  • Level of C-reactive protein

    Post first cell transplantation: 3 weeks and months 1,3 and 6

Study Arms (2)

UCMSC group

EXPERIMENTAL

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

Biological: UCMSC group

Control group(Normal saline)

OTHER

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

Other: Control group(Normal saline)

Interventions

UCMSC groupBIOLOGICAL

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

UCMSC group
Control group(Normal saline)OTHER

Normal saline in same volume as MSCs are transplanted to patients.

Control group(Normal saline)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of gastroenterology,Affiliated Hospital to Academy of Military Medical Sciences

Beijing, 100071, China

RECRUITING

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Bing Liu, M.D.

    307-IVY Translational Medicine Center

    STUDY CHAIR

  • Yan Liu, M.D.

    Department of gastroenterology,Affiliated Hospital to Academy of Military Medical Sciences

    STUDY DIRECTOR

  • Min Min, M.D.

    Department of gastroenterology,Affiliated Hospital to Academy of Military Medical Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yan Liu, M.D.

CONTACT

+86-010-6694747313911798288@163.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2015

First Posted

May 13, 2015

Study Start

May 1, 2015

Primary Completion

May 1, 2017

Study Completion

December 1, 2017

Last Updated

May 15, 2015

Record last verified: 2015-05

Locations

CN(1)