Mesenchymal Stem Cells in Critical Limb Ischemia

Critical Limb Ischemia Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00883870
• Other study ID #: SRPL/CLI/07-08/001
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: April 17, 2009
• Last updated: March 4, 2013
• Start date: April 2009
• Est. completion date: August 2012

Study information

• Verified date: March 2013
• Source: Stempeutics Research Pvt Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Drugs Controller General of India
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 2012
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Critical Limb Ischemia
• Ischemia

Intervention

Drug:
• mesenchymal stem cells
Intramuscular injection
• Plasmalyte A
Intramuscular injection

Locations

Country	Name	City	State
India	Bhagawan Mahaveer Jain Heart Centre	Bangalore	Karnataka
India	M.S.Ramaiah Memorial Hospital	Bangalore	Karnataka
India	Amrita Institute of Medical Sciences	Kochi	Kerala
India	Sri Ganga Ram Hospital	New Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Stempeutics Research Pvt Ltd

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AE and symptomatic relief		6 months	Yes
Secondary	Increase in transcutaneous partial oxygen pressure (TcPO2) and Ankle brachial pressure index (ABPI) - measured by Doppler		6 months	No