The Evolution Of Biologics In The Life Sciences Industry ® Regrow
Autologous Cell Therapy System Satyen Sanghavi
M.Sc. Stem Cell Technology, Univ. of Nottingham, U.K. Chief Scientific Officer / Executive Director, Regrow. Disclaimer: The views expressed in this message are made in an individual capacity and do not necessarily reflect those of Regrow (the company) or any of its affiliates. Neither the company nor any of its affiliates assumes any responsibility or liability for any use which may be made of any views expressed herein.
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Company Info • Vision is to be a front runner in the stem cell & regenerative medicine industry in India. • Established: 2008 • 3 verticals: Cell Therapy, Cord blood stem cell banking, wound healing. • CEO: Yash Sanghavi (30+ years in pharmaceutical and insurance industry) • Headquarters: Mumbai + 28 regional offices across India (self-owned & franchisee) • Investment: INR 60 cr (~USD 10 Million) • No. of Employees: 220 (45 at facility) 2
Regenerative Medicine Regenerative Medicine with Cell &Tissue Engineering
Isolation
Propagation
Cells
Biopsy
± Scaffold • Replace • Repair • Restore • Regenerate
± Signals • Cytokines • GF 3
Regenerative Medical Practice Regenerative medical practice include diagnosis, tissue harvesting, human cell treatment, implantation and rehabilitation. RMP is the prevention or treatment of human diseases by the administration of cells that have been selected, multiplied and medically treated outside the body. The implanted cells can release the therapeutic substance at a constant rate determined by the cellular feedback mechanism, which regenerates human tissue.
Diagnosis
Rehabilitation
Tissue Harvesting
Implantation Human Cell Treatment
Procedure / Quality control 4
Cell Therapy - Concept ² Cell therapy can be defined as therapy in which a product / medicine / drug of cellular nature / material is implanted /injected into same or another patient with aim to restore normal tissue/ organ function. ² Cells through its repair mechanism of self renewal or differentiation can pause the progression / repair damaged body part / reverse medical condition. This has proven useful in treatment of several acute & chronic diseases. ² Goes a step further from current medicine and recombinant products available in market. ² Stem cell products in areas like orthopedics have become mainstream and widely used as the recommended therapy instead of replacement surgeries. ² According to Axis Research Mind, the global stem cell therapy market was pegged at USD 21 Billion in 2010 and is expected to cross USD 60 Billion by 2015, tripling in size. 5
Autologous Vs. Allogeneic A procedure in which patient’s own stem cells are used for treatment.
In allogeneic cell therapy the donor & recipient are different and involves more development time.
Autologous cell therapy have the advantage of lower risk of infection, rare chance of patients experiencing rejection (graft-versus-host disease) due to the donor and recipient being the same individual.
In most cases, the success of allogeneic transplantation depends in part on how well (HLA testing) the donor’s stem cells match those of the recipient’s stem cells.
e.g. Adult Stem cells from bone marrow, Peripheral Blood, iPS cells from skin biopsy.
e.g. Umbilical cord blood, allogeneic stem cell pooling from donor bone marrow, skin grafts, organ 6 transfer.
Stem Cell opportunity for Orthopedics Market §
Worldwide, osteoarthritis (OA) is estimated to be the fourth leading cause of disability. [1]
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Community survey data in rural & urban areas of India shows the prevalence of osteo-arthritis is in the range of 17 to 60.6%. [2]
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Approx. 1.3 millions children suffering of juvenile arthritis in India, and increasing. [3]
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South-East Asia contributes to 31% of world burden and 27% of sport injury related morbidities [3]
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In 2012, the global orthopedics market is forecast to have a value of $22.9 billion, an increase of 41.7% since 2007. (Orthopedics Global Industry Guide)
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The Indian stem cell therapy market is projected to grow at an annual growth rate of around 15% (2010 India was $2 billion), driven by robust investment from the government and private players. (Market report by Axis Research Mind)
In India More than 175 million people are suffering from different orthopedic problems
Hip and Knee products contributes to over 60 % of market share
The orthopedic market estimated to be at over $ 2Bn Orthopedic market Increasing at 7 over 15 % each year
Revision joint Replacement
PAIN RELIEF Total Joint Replacement IA – Steroids / HA
Pharmaceu;cals
REPLACEMENT
Overall quality of life
Severity of the disease
Patient Journey
Lifestyle changes / Nutraceu;cals
Pa$ent life$me
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Revision joint Replacement
PAIN RELIEF GAP
IA – Steroids / HA Pharmaceu;cals
Total Joint Replacement
For many Pa$ents relief is no longer effec$ve but too young for replacement
REPLACEMENT
Overall quality of life
Severity of the disease
Filling the gap
Lifestyle changes / Nutraceu;cals
Pa$ent life$me • Almost 120,000 joint replacement surgeries were performed in India in the year 2012.
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Revision joint Replacement
Biologics Total Joint Replacement
PAIN RELIEF CELL THERAPY IA – Steroids / HA
REPLACEMENT
Overall quality of life
Severity of the disease
New Options
Pharmaceu;cals Lifestyle changes / Nutraceu;cals
REGENERATION
Pa$ent life$me
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CHONDRON®
(Autologous Chondrocyte Implantation)
Cartilage Biopsy
Final Product
P1 Stage
P2 Stage
Final Process Stage
Processing and manufacturing of the cells as per GMP 11
CHONDRON® Case Reports SHOULDER KNEE
Pre Op
Post Op Pre Op
PATELLA (KNEE CAP)
Post Op
ANKLE
Pre Op
Post Op Pre Op
Post Op
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Bone Disorders •
It is estimated that by 2018 more than 50% of all osteoporotic fractures will occur in Asia.
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Approx. 50,000 hip replacements surgeries / year in India (2011). 40% cause has been recorded due to AVN.
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Around 0.4 million new fracture cases in Indian every year, a figure set to hit 1million by 2015.
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India accounts for 86% of oral cancer of Asia. Significant bone & soft tissue loss post surgery.
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Osteoporosis is one of the most common diseases affecting 1 in 3 women and 1 in 12 men by the end of their lives.
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In India- osteoporosis patients are estimated around 26 million and the numbers are projected to increase to 36 million by 2014 13
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OSSRON™ (Autologous Bone Implantation) ´ Bone regeneration by autologous progenitor cell technology. ´ It involves the isolation of the osteo-progenitor cells from patient bone marrow and then differentiation with cytokines & GFs to osteoblasts. ´ These osteoblasts are then expanded and implanted at defect site. ´ Eliminates the problems of donor site morbidity for autologous grafts, the immunological problems of allogeneic grafts and provides 3D bone growth. 14
OSSRONTM - Procedure
v Obtain bone marrow specimen from the anterior or posterior iliac crest. v Harvest 2-‐5ml bone marrow. v Put the harvested bone marrow into BM transport boUle containing media and an;coagulants. v Shake the boUle to mix the bone marrow with an;coagulant. v The bone marrow should be transported to RMS laboratory within 48 hours aXer biopsy.
OSSRONTM - Procedure Tissue Harvest
Obtain bone marrow specimen form the anterior or posterior iliac crest
Cell Culture
Process isolated cells from the harvested bone marrow for approx. weeks
Ossron Implanta;on
Implant the cultured autologous bone cells to injured bone.
AXer implanta;on
Regenerated bone
OSSRON™ Case Reports
ORAL & MAXILO
Pre Op
Post Op
AVASCULAR NECROSIS BONE GAP
Pre Op
Post Op NON-‐UNION FRACTURE
Pre Op
Post Op
LIMB LENGTHENING
Pre Op
Post Op
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Thank You for Your Attention.
Regenerative Medical Services Pvt. Ltd. 2-ABC, Acme Plaza, Andheri [E], Mumbai 400 059, India. Tel +91 22 67330300 Fax +91 22 28390556 E-mail
[email protected] /
[email protected] Website www.regrow.in / www.babycell.in
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