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Mesenchymal Stem Cells in Critical Limb Ischemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stempeutics Research Pvt Ltd
ClinicalTrials.gov Identifier:
NCT00883870
First received: April 17, 2009
Last updated: March 4, 2013
Last verified: March 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Critical Limb Ischemia
 Drug: mesenchymal stem cells
Drug: Plasmalyte A
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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)

Resource links provided by NLM:

Drug Information available for: Normosol R
U.S. FDA Resources

Further study details as provided by Stempeutics Research Pvt Ltd:

Primary Outcome Measures:
  • AE and symptomatic relief [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Increase in transcutaneous partial oxygen pressure (TcPO2) and Ankle brachial pressure index (ABPI) - measured by Doppler [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: April 2009
Study Completion Date: August 2012
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: mesenchymal stem cells
Intramuscular injection
 Drug: mesenchymal stem cells
Intramuscular injection
Experimental: Placebo
Intramuscular injection
 Drug: Plasmalyte A
Intramuscular injection

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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,
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00883870

Locations
India
Bhagawan Mahaveer Jain Heart Centre
Bangalore, Karnataka, India, 5660052
M.S.Ramaiah Memorial Hospital
Bangalore, Karnataka, India, 560054
Amrita Institute of Medical Sciences
Kochi, Kerala, India, 682026
Sri Ganga Ram Hospital
New Delhi, India, 110060
Sponsors and Collaborators
Stempeutics Research Pvt Ltd
Investigators
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
  More Information

No publications provided

Responsible Party: Stempeutics Research Pvt Ltd
ClinicalTrials.gov Identifier: NCT00883870     History of Changes
Other Study ID Numbers: SRPL/CLI/07-08/001
Study First Received: April 17, 2009
Last Updated: March 4, 2013
Health Authority: India: Drugs Controller General of India

Keywords provided by Stempeutics Research Pvt Ltd:
mesenchymal stem cells
critical limb ischemia

Additional relevant MeSH terms:
Ischemia
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013