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Cell Therapy With Mesenchymal Stem Cell in Ischemic Limb Disease

NCT02336646 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2021-08-25

No results posted yet for this study

Summary

Bone marrow MSCs will be isolated from allogenic donors, expanded under hypoxic conditions using medium containing no serum or animal-derived reagents, and applies for Phase Ⅰ/Ⅱ study in treating 18 recipients with ischemic limb diseases.

Conditions

  • Critical Limb Ischemia

Interventions

DRUG

Allogenic MSC

Hypoxia-cultured human bone marrow derived mesenchymal stem cells

DRUG

Normal saline

Sponsors & Collaborators

  • Taiwan Bio Therapeutics Inc.

    lead INDUSTRY

Principal Investigators

  • Chun Che Shih · Taipei Veterans General Hospital, Taipei, Taiwan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-01
Primary Completion
2018-04-27
Completion
2018-12-20

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02336646 on ClinicalTrials.gov