Mesenchymal Stem Cells in Critical Limb Ischemia

NCT00883870 | Completed Phase 1 DMC

• 1 other identifier: SRPL/CLI/07-08/001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Critical Limb Ischemia

Keywords

mesenchymal stem cells; critical limb ischemia

Outcome Measures

Primary Outcomes (1)

• AE and symptomatic relief

  6 months

Secondary Outcomes (1)

• Increase in transcutaneous partial oxygen pressure (TcPO2) and Ankle brachial pressure index (ABPI) - measured by Doppler

  6 months

Study Arms (2)

mesenchymal stem cells

EXPERIMENTAL

Intramuscular injection

Drug: mesenchymal stem cells

Placebo

EXPERIMENTAL

Intramuscular injection

Drug: Plasmalyte A

Interventions

mesenchymal stem cells DRUG

Intramuscular injection

mesenchymal stem cells

Plasmalyte A DRUG

Intramuscular injection

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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,

Sponsors & Collaborators

• Stempeutics Research Pvt Ltd: lead

Study Sites (4)

M.S.Ramaiah Memorial Hospital

Bangalore, Karnataka, 560054, India

Location

Bhagawan Mahaveer Jain Heart Centre

Bangalore, Karnataka, 5660052, India

Location

Amrita Institute of Medical Sciences

Kochi, Kerala, 682026, India

Location

Sri Ganga Ram Hospital

New Delhi, New Delhi, 110060, India

Location

Related Publications (1)

• 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.

  PMID: 23758736 DERIVED

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia

Interventions

Plasmalyte A

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2009
• First Posted: April 20, 2009
• Study Start: April 1, 2009
• Primary Completion: February 1, 2010
• Study Completion: August 1, 2012
• Last Updated: March 5, 2013

Record last verified: 2013-03

Locations

IN (4)