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Mesenchymal Stem Cells in Critical Limb Ischemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00883870
Recruitment Status : Completed
First Posted : April 20, 2009
Last Update Posted : March 5, 2013
Information provided by (Responsible Party):
Stempeutics Research Pvt Ltd

Brief Summary:
This clinical trial aims to study the safety and efficacy of adult mesenchymal stem cells in critical limb ischemia.

Condition or disease Intervention/treatment Phase
Critical Limb Ischemia Drug: mesenchymal stem cells Drug: Plasmalyte A Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double Blind, Multicentric, Placebo Controlled, Single Dose, Phase - i/ii Study Assessing the Safety and Efficacy of Intramuscular ex Vivo Cultured Adult Allogenic Mesenchymal Stem Cells in Patients With Critical Limb Ischemia (Cli)
Study Start Date : April 2009
Actual Primary Completion Date : February 2010
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: mesenchymal stem cells
Intramuscular injection
Drug: mesenchymal stem cells
Intramuscular injection

Experimental: Placebo
Intramuscular injection
Drug: Plasmalyte A
Intramuscular injection

Primary Outcome Measures :
  1. AE and symptomatic relief [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Increase in transcutaneous partial oxygen pressure (TcPO2) and Ankle brachial pressure index (ABPI) - measured by Doppler [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Males or females with non-child bearing potential in the age group of 18-60 yrs of Indian origin.
  • Established CLI, clinically and hemodynamically confirmed as per Rutherford- II-4, III-5, or III-6; Patients having Infra-inguinal arterial occlusive disease with rest pain or ischemic ulcer/necrosis, who are not eligible for or have failed traditional revascularization treatment (No option patients)
  • Ankle Brachial Pressure Index (ABPI) ≤ 0.6 or ankle pressure ≤ 70 mm Hg or TcPO2 ≤ 60 mmHg in the foot
  • Patients if having associated Type II Diabetes, should be on medication and well controlled (HbA1c ≤ 8%) without complications
  • Patients who are able to understand the requirements of the study, and willing to provide voluntary written informed consent, abide by the study requirements, and agree to return for required follow-up visits
  • Normal liver and renal function
  • On regular medication for hypertension if any

Exclusion Criteria:

  • Patients with CLI suitable for surgical or percutaneous revascularization as determined by the surgeon performing vascular procedure and patients with any acute/chronic inflammatory condition
  • CLI patient requiring amputation proximal to trans-metatarsal level
  • Patients with gait disturbance for reasons other than CLI.
  • Type I diabetes
  • Patients having respiratory complications/left ventricular ejection fraction < 25%f) Stroke or myocardial infarction within last 3 months
  • Patients who are contraindicated for MRA
  • Have clinically serious and/or unstable inter-current infection, medical illnesses or conditions that are uncontrolled or whose control, in the opinion of the Investigator, may be jeopardized by participation in this study or by the complications of this therapy
  • Documented terminal illness or cancer or any concomitant disease process with a life expectancy of less than 1 year
  • Patients already enrolled in another investigational drug trial or completed within 3 months.
  • History of severe alcohol or drug abuse within 3 months of screening.
  • Hb% < 10 gm%, Serum Creatinine ≥ 2mg%, Serum Total Bilirubin ≥2mg%, HbA1c > 8%
  • Women with child bearing potential, pregnant and lactating women.
  • Patients tested positive for HIV 1, HCV, HBV,

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00883870

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M.S.Ramaiah Memorial Hospital
Bangalore, Karnataka, India, 560054
Bhagawan Mahaveer Jain Heart Centre
Bangalore, Karnataka, India, 5660052
Amrita Institute of Medical Sciences
Kochi, Kerala, India, 682026
Sri Ganga Ram Hospital
New Delhi, India, 110060
Sponsors and Collaborators
Stempeutics Research Pvt Ltd
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Principal Investigator: Suresh K R Bhagawan Mahaveer Jain Heart Centre, Bangalore
Principal Investigator: Sanjay Desai M.S.Ramaiah Memorial Hospital, Bangalore
Principal Investigator: Rajiv Parakh Sri Ganga Ram Hospital, New Delhi
Principal Investigator: Sudhindran S Amrita Institute of Medical Sciences, Kochi
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Stempeutics Research Pvt Ltd Identifier: NCT00883870    
Other Study ID Numbers: SRPL/CLI/07-08/001
First Posted: April 20, 2009    Key Record Dates
Last Update Posted: March 5, 2013
Last Verified: March 2013
Keywords provided by Stempeutics Research Pvt Ltd:
mesenchymal stem cells
critical limb ischemia
Additional relevant MeSH terms:
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Pathologic Processes
Plasma-lyte 148
Ophthalmic Solutions
Pharmaceutical Solutions