NCT01221428

Brief Summary

The purpose of this study is to determine whether umbilical cord Mesenchymal Stem Cells of treatment for ulcerative colitis is safe and effective.

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
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2010

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

September 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 14, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 15, 2010

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

October 15, 2010

Status Verified

July 1, 2010

Enrollment Period

2 years

First QC Date

October 14, 2010

Last Update Submit

October 14, 2010

Conditions

Ulcerative ColitisMesenchymal Stem CellsUmbilical Cord

Keywords

Ulcerative colitisMesenchymal Stem CellsUmbilical Cord

Outcome Measures

Primary Outcomes (1)

  • the result of enteroscopy and pathological report

    3 months

Secondary Outcomes (1)

  • the clinical symptom (including stomachache,abdominal distention,bloody purulent stool)

    3 months

Study Arms (1)

umbilical cord mesenchymal stem cells

EXPERIMENTAL

Intravenous infusion of ex vivo cultured umbilical cord mesenchymal stem cells,one week later,conduct intervention operation to inject mesenchymal stem cells to mesenteric artery.

Biological: Umbilical Cord Mesenchymal Stem Cells

Interventions

Umbilical Cord Mesenchymal Stem CellsBIOLOGICAL

Intravenous infusion of ex vivo cultured umbilical cord mesenchymal stem cells(2\*10/7),one week later,conduct intervention operation to inject mesenchymal stem cells to mesenteric artery(1\*10/7).

Also known as: Mesenchymal Stem Cells
umbilical cord mesenchymal stem cells

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female, 18 years of age or older.
  • Ulcerative colitis described according to usual criteria.
  • Refractoriness Ulcerative colitis or unefficient by using other therapy
  • Signed informed consent form.

You may not qualify if:

  • History of neoplasm or hematological disease
  • Uncontrolled high blood pressure (\>180/110)
  • Severe cardiac insufficiency (New York Heart Association \[NYHA\] IV) or ejection fraction\<30%
  • Malignant ventricular arrythmia
  • Deep venous thrombosis during the last 3 months
  • Active bacterial infection
  • Body mass index \> 35 Kg/m2
  • Stroke or myocardial infarction during the last 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stem Cell Research Center of Medical School Hospital of Qingdao University

Qingdao, Shandong, 266003, China

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Gang Zhao, MD

    The Affiliated Hospital of Qingdao University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 14, 2010

First Posted

October 15, 2010

Study Start

September 1, 2010

Primary Completion

September 1, 2012

Study Completion

December 1, 2012

Last Updated

October 15, 2010

Record last verified: 2010-07

Locations

CN(1)