Idiopathic Pulmonary Fibrosis Clinical Trial
Official title:
A Prospective, Multicentric, Phase I/II, Open Label, Randomized, Interventional Study to Evaluate the Safety and Efficacy of Intravenous Autologous Adipose Derived Adult Stem Cells for Treatment of Idiopathic Pulmonary Fibrosis (IPF).
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
Adipose Derived Stromal Vascular Fraction (ADSVF) Stromal Vascular Fraction (SVF) obtained
from tumescent liposuction. The SVF contains a variety of cells such as pre-adipocytes,
endothelial cells, smooth muscle cells, pericytes, fibroblasts, and adult stem cells (ASCs).
In addition, the SVF also contains blood cells from the capillaries supplying the fat cells.
These include erythrocytes or red blood cells, B and T cells, macrophages, monocytes, mast
cells, natural killer (NK) cells, hematopoietic stem cells and endothelial progenitor cells,
to name a few. It also contains growth factors such as transforming growth factor beta
(TGF-β), platelet-derived growth factor (PDGF), and fibroblast growth factor (FGF), among
others. This is consistent with the secretions of cells in the presence of an extracellular
matrix. The SVF also contains the various proteins present in the adipose tissue
extracellular matrix of which laminin is of interest due to its ability to help in neural
regeneration.Entire procedure for SVF preparation and isolation of SVF cells will be carried
out in cGMP compliance clean room.
Pure stromal vascular fraction to the tune of 99% will be isolated for this clinical trial
eliminating other unnecessary cells such as RBC and leukocytes.
Adipose Derived Mesenchymal Stem Cells (ADMSC) Human mesenchymal stem cells (MSCs) are
present as a rare population of cells in adipose tissue which is almost 30-40% of the
nucleated cells, but they can rapidly grow in culture without losing their stemness. MSCs
can be expanded in vitro ≥ 2 million -fold and retain their ability to differentiate into
several mesenchymal lineages. MSCs have several characteristics such as Ease of isolation,
High expansion potential,Genetic stability,Reproducible attributes from isolate to
isolate,Reproducible characteristics, Compatibility with tissue engineering principles,
Potential to enhance repair in many vital tissues, Uniform dose and Better quality control
and release criteria.
Beside autologous use MSC can also be used for allogenic therapy. Several studies have used
allo-MSC in vivo and experience suggests that the allo-MSCs are not rejected and many have
positive effects on engraftment.MSC's can be isolated from various tissues, cultured ex
vivo, and expanded many fold.18 Cultured-expanded MSC's appear to represent a homogeneous
population by flow cytometric measures of cell-surface markers. These cell retain the
ability to undergo in vitro differentiation to osteogenic, adipogenic and chondrogenic
lineages, even when clonally expanded.19 Human adipose tissue derived MSCs are capable of
differentiating into endothelial cells in vitro and later form capillary-like structures in
semisolid medium and suggest differentiation potential of MSCs is not restricted to
mesodermal lineages but also transdifferentiation of MSCs into other lineages like
endothelial could be realized in vitro and in vivo8 MSCs are known to give rise to limb-bud
mesoderm (osteoblasts, chondrocytes, adipocytes, stroma cells, and skeletal myoblasts) and
can also differentiate into cells of visceral mesoderm (endothelial cells).9 MSCs can
facilitate vasculogenesis by increasing vascular endothelial growth factor (VEGF) levels.
After MSCs are intramyocardially injected into the infarct zone, local VEGF levels rise,
vascular density and regional blood flow increases, and contractility improves.
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 neighboring cells and to the extra cellular matrix.18 This
cell surface configuration may enable mesenchymal stem cells to home from bloodstream to
mesenchymal tissue.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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