Evaluate Safety and Efficacy of Intravenous Autologous ADMSc for Treatment of Idiopathic Pulmonary Fibrosis

Summary

Despite intense research efforts and clinical trials, there is still no effective treatment that can prolong the survival of patients with IPF. Conventional therapeutic approach includes combination of corticosteroids, anti-oxidants, immunodepressants and immune modulatory anti-fibrotic agents to be discontinued 20 days before screening. The only, so far, therapeutic approach that has been proven effective in terms of prolonging patient's survival is lung transplantation. Nonetheless, not all the patients with IPF are eligible for lung transplantation; there is a significant proportion of these patients that finally succumb while waiting in a lung transplantation list. Therefore, there is critical need for more effective and reliable therapeutic modalities5. Adult Stem Cells (ASCs) seem to represent one of these. Therefore, it is conceivable to assume that adult-stem cells can be easily and safely be applied as a novel therapeutic agent in chronic and fatal lung diseases, including chronic obstructive pulmonary disease (COPD) and IPF.

Therefore, there is an urgent need to provide a safe, effective and affordable treatment option for IPF patients. New diagnostic, prognostic and therapeutic strategies need to be developed to reduce the burden of IPF. Given the present lack of appropriate treatment adjunctive in the therapy of IPF, adipose derived stromal vascular fraction provides new opportunities for development of the same.

MSCs are having anti-fibrotic activity and hence may be excellent source to tackle pulmonary fibrosis and hence could be explored for their therapeutic potential for treating Idiopathic pulmonary fibrosis. MSC's also display membrane-bound and insoluble secreted molecules involved with cell attachment to neighbouring cells and to the extra cellular matrix.18 This cell surface configuration may enable mesenchymal stem cells to home from bloodstream to mesenchymal tissue.14

As limited clinical information is available about use of SVF and MSC in the IPF patients hence this Open Label, Prospective, Randomized multi center comparative study has been undertaken to explore the tolerability \& effectiveness of SVF in one treatment arm and MSC in second treatment arm in IPF patients.

Adipose derived stromal vascular fraction and Mesenchymal Stem Cells has been found in preclinical studies to be safe and effective

Conditions

• Idiopathic Pulmonary Fibrosis

Interventions

BIOLOGICAL

Autologous Stromal Vascular Fraction (SVF)

Study arm A subjects will receive single dose of autologous adipose derived Stromal Vascular Fraction (SVF) intravenously.

BIOLOGICAL

Autologous Adipose Derived MSCs (ADMSCs)

Study arm B subjects will receive total 3 doses of 2 million per kg body weight adipose tissue derived Ex-vivo expanded Mesenchymal stem cells (MSC) intravenously each. All the three doses will be given at weekly intervals.

OTHER

Control

Standard Therapy

Sponsors & Collaborators

• Kasiak Research Pvt. Ltd.

  lead INDUSTRY

Principal Investigators

• Dr. Ashok A Mahashur, M.B.B.S.M.D. · P.D. Hinduja National Hospital and Medical Research Centre

• Dr. Pratibha S Singhal, M.B.B.S.M.D. · Bombay Hospital and Medical Research Council

• Dr.Sujeet K Rajan, M.B.B.S.M.D. · Bhatia General Hospital

• Dr. Kartik B Shah, M.B.B.S.M.D. · Cumballa Hill Hospital And Heart Institute

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

30 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-08-31

Primary Completion

2015-08-31

Countries

• India

Study Locations