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A Clinical Trial to Study the Efficacy and Safety of Different Doses of Bone Marrow Derived Mesenchymal Stem Cells in Patients With Critical Limb Ischemia Due to Buergers Disease

NCT01484574 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2016-09-13

No results posted yet for this study

Summary

This is an open label, non-randomized, dose ranging study to evaluate the safety and efficacy of different doses of Stempeucel in critical limb ischemia patients.

Conditions

  • Critical Limb Ischemia
  • Buerger's Disease

Interventions

BIOLOGICAL

Allogeneic Mesenchymal Stem Cells

Single intramuscular administration of low dose of stem cells

BIOLOGICAL

Allogeneic Mesenchymal Stem Cells

Single intramuscular administration of intermediate dose of stem cells

Sponsors & Collaborators

  • Stempeutics Research Pvt Ltd

    lead INDUSTRY

Principal Investigators

  • Dr Anirban Chatterjee · AMRI Hospital

  • Dr Anita Dhar · All India Institute of Medical Sciences

  • Dr Rajkumar M · Stanley Medical College

  • Dr Radhakrishnan R · Sri Ramchandra Medical College

  • Dr Vidyasagaran T · Madras Medical College

  • Dr Alfred Augustine · KMC, Mangalore

  • Dr Sanjay Desai · M. S. Ramaiah Medical College

  • Dr Rajiv Parakh · Medanta - The Medicity

  • Dr Santanu Dutta · Nightingale Hospital

  • Dr Murali Krishna · Sri Jayadeva Institute of Cardiovascular Sciences & Research

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2014-02-28
Completion
2016-03-31

Countries

  • India

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 NCT01484574 on ClinicalTrials.gov