Starting a HCT program A perspective from India

Alok Srivastava
Department of Haematology Christian Medical College Vellore, India

1 Personnel

2 Institutional Support

3 Physical Environment 5 Protocols & SOPs

4 Medical Infrastructur 6 e Phased Development

Successful HSCT Program

7 Business Model

Establishing a successful HSCT program

Establishing a successful HSCT program 1.Developing appropriate personnel

1.Physicians Comprehensive training (2-3 years) in hematology and transplantation (Most critical) 2.Resident physicians 3.Nurses Very critical component, need a team, 1 to 1 nursing, if possible 4.Consultative support Histopathology, Radiologists, Clinical consults: Gastroenterology, Nephrology, Neurology , Cardiology, others 5.Apheresis / cryopreservation staff 6.Transplant coordinators / counselors 7.Housekeeping staff / Engineers

Establishing a successful HSCT program 2.Physical Environment

1.Transplant rooms HEPA filtered 2.Water clean 3.Food supply ?Sterile 4.Support departments Central sterile supply 5.Protocols for entry / exit 6.Protocols for housekeeping 7.Microbiological monitoring of air and water

CHRISTIAN MEDICAL COLLEGE, VELLORE, INDIA (ESTD: 1900)

Streets around CMC, Vellore

Establishing a successful HSCT program 3.Institutional support

1.Critical for developing the - team of personnel - physical environment for HSCT - medical infrastructure 2.Provide necessary space and financial support for establishing infrastructure for what may appear esoteric at first

Establishing a successful HSCT program 4.Medical infrastructure

1.HLA typing Institutional / outsourced 2.Insertion of Hickman / Broviac catheters 3.Blood bank with components platelets / plasma 4.Apheresis instruments for PBSC / platelets 5.Blood irradiation facilities 6.Round the clock laboratory services: Hematology (Flowcytometry / Molecular genetics graft assessment / chimerism) Biochemistry Microbiology bacterial / fungal / viral infections (quantitation, if possible) 7.Pharmacy services: Drugs / TPN / other requirements

Establishing a successful HSCT program 5.Establishing protocols and SOPs

Important to have clearly defined policies and protocols for everything 1.Pre-transplant evaluation (recipient & donor) 2.Conditioning regime 3.Harvest of stem cells BM / PBSC 4.Cultures and antibiotics prophylaxis, if any 5.GVHD prophylaxis and (?treatment) 6.Post-transplant follow-up and care Taper of GVHD prophylaxis Monitoring of engraftment / chimerism Immunization protocol 7.Long term follow-up protocols 8.Systematic data recording for analysis and quality management

Establishing a successful HSCT program 6.Phased development

1.Build team through practice of intensive hematology managing chemotherapy and cytopenias with transfusions / antibiotics / other supportive measures 2.Careful selection of initial patients 3.Start with autologous, if possible, for multiple myeloma and then lymphomas when cryopreservation becomes possible. 4.Move to matched related allogeneic transplants in good risk patients before doing high risk / alternative donor transplants 5.Collegial atmosphere for discussion / questions in the team 6.Keep up with relevant literature and technology, as much as possible Introduce research into clinical practice 7.Develop a team that communicates well patients and

Establishing a successful HSCT program 7.The business model (if relevant)

1.Even if fully supported by government funds, need to evolve a program that is financially sustainable within that health care system 2.If in the private sector (insurance / self pay), need to develop a cost structure that allows even those with limited resources to access the program

1986 (1 bed)

1990 (3 beds)

2008 10+8 beds Phased development of the Stem Cell Transplant Unit at CMC, Vellore, India

BONE MARROW TRANSPLANTATION CMC (Oct 1986 - Dec 2010)

160 140 No. of transplants 120 100 80 60 40 20
1986 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010

Allogeneic-1004

Autologous-306

Years

-Matched related : Avg cost - US $ 20,000 -Matched unrelated (since 2008) : Avg cost US $ 50-100,000 -Haplo identical (since 2006) : Avg cost US $ 20-50,000

INDICATIONS FOR BMT CMC, Vellore (Oct 1986 - Dec 2010)

Allogenic transplant (n=1004)
Myelodysplastic Syndrome 5% Acute Lyphoblastic Leukemia 8% Myelofibrosis PNH 1% 1% FA 1% APML 1% Other Malignancies <1% PRCA <1%

Thalassemia 34%

Chronic Myeloid Leukemia 12%

Aplastic Anaemia 16%

Rare genetic disorder 1%

(Diamond Blackfan-3 Severe Combined Immuno Deficiency-3 Wiscott Aldrich Syndrome-4 Dyskeratosis congenita-1 Osteopetrosis-1 Adrenoleukodystrophy-1 Kostmann Syndrome-1 Congenital Sideroblastic anaemia-1)

Acute Myeloid Leukemia 20%

INDICATIONS FOR BMT CMC, Vellore (Oct 1986 - Dec 2010)

Autologous Transplant (n=306)
Acute Lymphoblastic Amyloidosis Leukemia Plasma cell Leukemia 1% Acute Promyelocytic 1% 1% Leukemia 8% Hodgkin Lymphoma 11% Granulocytic Sarcoma <1%

Multiple Myeloma 43%

Acute Myeloid Leukemia 17% Non-Hodgkin's Lymphoma 18%

(LUDHIANA)

Dr. Joseph John

(NEW DELHI)

(SRINAGAR)

Dr. Gh Jeelani Samoon Dr. Javid Rassol Bhat

Dr. Velu Nair Dr. Dinesh Bhurani Dr. Satyaranjan Das Dr. Sanjeevan Sharma
(AHMEDABAD)

Dr. Urmish Chudgar Dr. Ashwin Patel Dr. Uday R Deotare

(BHOPAL)

(INDORE)

Dr. Anil Singhvi

(KOLKATA)

Dr. Sunil Dabadghao

(AURANGABAD)

Dr. Suparno Chakraborty Dr. Siddhartha Sankar Ray Dr. Anupam Chakrapani
(BHUBANESHWAR)

Dr. Jayant Indurkar

(MUMBAI)

Dr. P.K. Das

(HYDERABAD)

Dr. Farah Jijina Dr. Abhay Bhave Dr. Sameer Shah

(PUNE)

Dr. A.M.V.R. Narendra Dr. Shailesh R Singhi Dr. Ravindra Votery

(BENGALURU)

Dr. S.J. Apte Dr. Ajay Sharma Dr. Vijay Ramanan Dr. Sameer Melinkeri Dr. Kannan. S
(COCHIN)

Dr. Cecil Ross Dr. Sharat Damodar

(CHENNAI)

Dr. Krishnarathnam. K
(COIMBATORE)

Dr. Manoj Unni

(TRIVANDRUM)

Dr. Suthanthira Kannan

Dr. Shruti Prem

Stem Cell Transplant Centers in India - 2011

Ludhina
Chandigarh

Delhi

Lucknow

Ahmedabad

Kolkata

Mumbai Pune Hyderabad

TRANSPLANT CENTERS IN INDIA

Manipal Chennai Bangalore Vellore

2001-2005

15

1996-2000

1991-1995

PRE 1990

Trivandrum

INDIAN STEM CELL TRANSPLANT REGISTRY Number of Transplants India (N=4015)

700

No. of transplants

600 500

Allo (N=2445)

Auto (N=1569)

242

400
187

204 141 144 147

300 200
66 108

346 55 184 194 275 229 251

100 0
1 3 2 1 0 1 4 3 2 2 5 1 17 6 35 12 39 13 47 17 38

34 26 59 85

52 76

53 91

56 93

123 101

143

1983 1984 1985 1986 1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010

Years

INDIAN STEM CELL TRANSPLANT REGISTRY Number of Transplants India (N=4015)

700
588 479 438 328341 251 190 144 119128 1 3 2 1 1 4 5 7 18 60 55 41 51 85 149 156 370

No. of transplants

600 500 400 300 200 100 0

0

1983 1984 1985 1986 1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010

Years

INDIAN STEM CELL TRANSPLANT REGISTRY

1200 1100 1000 900
No. of transplants
ALLO (2445) AUTO (1569)
306

800 700 600 500 400 300 200 100 0

269 241 59 228 121 8 91 1004

198 109 139 244 21 86 82 47 10 25 33 22 3 21 39 18 67 16 4 12 6 12 6 10 14 8 1 6 6 2 34 1 7 0 3 0

154 86

68

16 51

Starting a HCT program A perspective from India Possible to establish a state of the art facility for SCT if there are the -Right people -Strong commitment -Supportive institutional environment -Disseminate expertise to the rest of the country
Our team
Physicians: 6 Registrars: 15 Nurses: 22 Scientists: 4 Research Fellows: 20 Transplant / Research coordinators