Mesenchymal Stem Cells in Critical Limb Ischemia

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)

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

Study Overview

• Status: Completed
• Conditions: Critical Limb Ischemia
• Intervention / Treatment: Drug: mesenchymal stem cells; Drug: Plasmalyte A

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• India
  • New Delhi, India, 110060
    • Sri Ganga Ram Hospital
  • Karnataka
    • Bangalore, Karnataka, India, 5660052
      • Bhagawan Mahaveer Jain Heart Centre
    • Bangalore, Karnataka, India, 560054
      • M.S.Ramaiah Memorial Hospital
  • Kerala
    • Kochi, Kerala, India, 682026
      • Amrita Institute of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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,

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: mesenchymal stem cells; Intramuscular injection	Drug: mesenchymal stem cells; Intramuscular injection
Experimental: Placebo; Intramuscular injection	Drug: Plasmalyte A; Intramuscular injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
AE and symptomatic relief	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Increase in transcutaneous partial oxygen pressure (TcPO2) and Ankle brachial pressure index (ABPI) - measured by Doppler	6 months

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General Publications

• Gupta PK, Chullikana A, Parakh R, Desai S, Das A, Gottipamula S, Krishnamurthy S, Anthony N, Pherwani A, Majumdar AS. A double blind randomized placebo controlled phase I/II study assessing the safety and efficacy of allogeneic bone marrow derived mesenchymal stem cell in critical limb ischemia. J Transl Med. 2013 Jun 10;11:143. doi: 10.1186/1479-5876-11-143.

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (Actual): February 1, 2010
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: April 17, 2009
• First Submitted That Met QC Criteria: April 17, 2009
• First Posted (Estimate): April 20, 2009

Study Record Updates

• Last Update Posted (Estimate): March 5, 2013
• Last Update Submitted That Met QC Criteria: March 4, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Keywords: critical limb ischemia; mesenchymal stem cells
• Additional Relevant MeSH Terms: Pathologic Processes; Ischemia; Pharmaceutical Solutions; Ophthalmic Solutions; Plasma-lyte 148
• Other Study ID Numbers: SRPL/CLI/07-08/001