To Evaluate the Safety and Efficacy of IM and IV Administration of Autologous ADMSCs for Treatment of CLI

Summary

Various preclinical animal studies have shown the potential of stem cells in re-vascularising ischemic limbs and promoting collateral vessel formation. SVF have the potential to facilitate the formation of new blood vessels and skeletal muscle. Early pilot clinical studies indicate that stem-cell transplantation is feasible and may have beneficial effects in CLI. Injury or inflammation is a prerequisite for the participation of circulating stem cells to home and differentiate on to this microenvironment. The increased vascular permeability and expression of adhesion proteins like integrin assist in stem cell homing. The migratory capacity of stem cells is dependent on natural growth factors such as vascular endothelial growth factor (VEGF), Stromal cell derived factor (SDFI) and stem cell factor (SCF). The expression of VEGF, SDFI and SCF is highly unregulated in the hypoxic muscular tissue and is responsible for the recruitment of the stem cells to assist in the repair mechanism and consequent improvement in limb function.

In addition to the above regenerating potential of SVF, they have several advantages; they can be easily isolated without further culturing it. Most importantly SVF have shown to have significantly highest expression of pluripotent markers similar to that of human embryonic stem cells and yet they are non-tumorogenic and safe.

MSCs are having angiogenic activity and hence may be excellent source to develop neo-vasculature and hence could be explored for their therapeutic potential for treating Critical Limb Ischemia. MSC's also display membrane-bound and insoluble secreted molecules involved with cell attachment to neighbouring cells and to the extra cellular matrix19 Adipose derived Stromal vascular fraction and Mesenchymal Stem Cells has been found in preclinical studies to be safe and effective.

The current Phase I/II study of adipose derived stromal vascular fraction and Mesenchymal stem cells is conducted with the broad objective of establishing safety and efficacy.

Conditions

• Critical Limb Ischemia

Interventions

BIOLOGICAL

Autologous Stromal Vascular Fraction (SVF)

Study arm A subjects will receive single dose of autologous adipose derived Stromal Vascular Fraction (SVF) SVF divided in two fraction and infused intravenously and intramuscularly

BIOLOGICAL

Autologous Adipose Derieved MSCs

Study arm B subjects will receive one dose of 1 million per kg body weight adipose tissue derived Ex-vivo expanded Mesenchymal stem cells (MSC) intravenously and one dose of 1 million per kg body weight adipose tissue derived Ex-vivo expanded Mesenchymal stem cells (MSC) intramuscularly

OTHER

Control

Sponsors & Collaborators

• Kasiak Research Pvt. Ltd.

  lead INDUSTRY

Principal Investigators

• Dr. Arun B Bal, M.B.B.S.M.S. · SL Raheja Hospital

• Dr. Ashish S Johari, M.B.B.S.M.S. · Jaslok Hospital and Research Centre

• Dr. Meena Kumar, M.B.B.S.M.S. · L T M C and L T M M General Hospital ,Sion

• R Shekhar, M.B.B.S.M.S. · Kokilaben Dhirubai Ambani Hospital and Medical Research Institute

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-08-31

Primary Completion

2015-08-31

Countries

• India

Study Locations