Umbilical Cord Mesenchymal Stem Cells Infusion for Ulcerative Colitis

Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cells Infusion for Ulcerative Colitis

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01221428

Enrollment

Registered

2010-10-15

Start date

2010-09-30

Completion date

2012-12-31

Last updated

2010-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mesenchymal Stem Cells, Ulcerative Colitis, Umbilical Cord

Keywords

Ulcerative colitis, Mesenchymal Stem Cells, Umbilical Cord

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.

Detailed description

Ulcerative colitis is characterized as chronic and nonspecific inflammation of gastroenteritis tract．Nowadays，etiology and pathogenesis of UC have been unclear．Recent basic research has been revealed that stem cell can settle down in epithelium of gastroenteritis tract，which provide a hope for treating the disease.We hope umbilical cord Mesenchymal Stem Cells could not only address the need for epithelial cell replacement but also control of the autoimmune response to mocous membrane of colon.

Interventions

BIOLOGICALUmbilical Cord Mesenchymal Stem Cells

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).

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* 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.

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame
the result of enteroscopy and pathological report	3 months

Secondary

Measure	Time frame
the clinical symptom (including stomachache,abdominal distention,bloody purulent stool)	3 months

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026