Mesenchymal Stem Cells in Critical Limb Ischemia

Phase 1

Completed

• Conditions: Critical Limb Ischemia
• Interventions: Drug: Plasmalyte A; Drug: mesenchymal stem cells

• Registration Number: NCT00883870
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-04-17
• Study First Submitted QC: 2009-04-17
• Study First Posted: 2009-04-20
• Primary Completion: 2010-02
• Study Completion: 2012-08
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-04
• Last Update Posted: 2013-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Plasmalyte A	Intramuscular injection
mesenchymal stem cells	mesenchymal stem cells	Intramuscular injection

Primary Outcome Measures

Name	Time	Method
AE and symptomatic relief	6 months

Secondary Outcome Measures

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

Trial Locations

Locations (4)

Amrita Institute of Medical Sciences; 🇮🇳 Kochi, Kerala, India

M.S.Ramaiah Memorial Hospital; 🇮🇳 Bangalore, Karnataka, India

Bhagawan Mahaveer Jain Heart Centre; 🇮🇳 Bangalore, Karnataka, India

Sri Ganga Ram Hospital; 🇮🇳 New Delhi, India