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Intramuscular Mononuclear Cells and Mesenchymal Stem Cells Transplantation to Treat Chronic Critical Limb Ischemia

NCT01456819 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2015-04-10

No results posted yet for this study

Summary

This is a randomized and single blinded study aimed to compare the efficacy between intramuscular autologous bone marrow mononuclear cells plus mesenchymal stem cell implantation and intramuscular autologous bone marrow mononuclear cells implantation only in patients with chronic critical limb ischemia. Patients will be randomized into two groups of equal number; patients in one group will be implanted with mononuclear cells and mesenchymal stem cells, and the other implanted with mononuclear cells only in the area of affected limb.

Conditions

  • Critical Limb Ischemia

Interventions

BIOLOGICAL

Mononuclear and mesenchymal stem cells

Intramuscular administration into the ischemic limb

BIOLOGICAL

Mononuclear cells

Intramuscular administration into the ischemic limb

Sponsors & Collaborators

  • Cytopeutics Sdn. Bhd.

    collaborator INDUSTRY

  • National University of Malaysia

    lead OTHER

Principal Investigators

  • Hanafiah Harunarashid, MD · UKM Medical Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2015-12-31
Completion
2016-02-29

Countries

  • Malaysia

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 NCT01456819 on ClinicalTrials.gov