MedTrace Logo

Safety and Efficacy of Autologous Bone Marrow Mononuclear Cells in Patients With Severe Critical Limb Ischemia

NCT01472289 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2015-11-18

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to evaluate the safety and efficacy of the concentrated autologous bone marrow derived stem cells for the treatment of Critical Limb Ischemia patients.

Conditions

  • Critical Limb Ischemia

Interventions

OTHER

Autologous Bone Marrow Mononuclear cells (BMMNCs)

Multiple intramuscular injections of concentrated bone marrow derived mononuclear cells (0.5 cc/injection) into the ischemic muscle of the affected limb.

Sponsors & Collaborators

  • Thermogenesis Corp.

    collaborator INDUSTRY

  • TotipotentSC Scientific Product Pvt. Ltd.

    lead INDUSTRY

Principal Investigators

  • Venkatesh Ponemone, PhD · TotipotentRX, Center for Cellular Medicine

  • Kenneth Harris, MS · TotipotentRX, Centre for Cellular Medicine

  • Suhail Bukhari, MBBS, FNBE · Fortis Escorts Heart Institute and Research Centre

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2013-01-31
Completion
2013-07-31

Countries

  • India

Study Locations

More Related Trials

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 NCT01472289 on ClinicalTrials.gov