Clinical trial NCT00883870: Mesenchymal Stem Cells in Critical Limb Ischemia
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Critical Limb Ischemia
Keywords: mesenchymal stem cells
critical limb ischemia
Lead sponsor: Stempeutics Research Pvt Ltd
Sponsor class: INDUSTRY
First posted: 2009-04-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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,

Primary outcomes:
measure: AE and symptomatic relief
timeFrame: 6 months
Secondary outcomes:
measure: Increase in transcutaneous partial oxygen pressure (TcPO2) and Ankle brachial pressure index (ABPI) - measured by Doppler
timeFrame: 6 months
Other outcomes:
Locations:
city: Bangalore
country: India
facility: M.S.Ramaiah Memorial Hospital
state: Karnataka
city: Bangalore
country: India
facility: Bhagawan Mahaveer Jain Heart Centre
state: Karnataka
city: Kochi
country: India
facility: Amrita Institute of Medical Sciences
state: Kerala
city: New Delhi
country: India
facility: Sri Ganga Ram Hospital
Study officials:
affiliation: Bhagawan Mahaveer Jain Heart Centre, Bangalore
name: Suresh K R
role: PRINCIPAL_INVESTIGATOR
affiliation: M.S.Ramaiah Memorial Hospital, Bangalore
name: Sanjay Desai
role: PRINCIPAL_INVESTIGATOR
affiliation: Sri Ganga Ram Hospital, New Delhi
name: Rajiv Parakh
role: PRINCIPAL_INVESTIGATOR
affiliation: Amrita Institute of Medical Sciences, Kochi
name: Sudhindran S
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.