Umbilical Cord Stem Cell Umbilical Cord Stem Cell BankingBanking

• Cell – smallest functional unit in human body.• Stem Cells are MASTER CELLS.• Unspecialized cells >> can specialize into 200 different cell types.• Make up the baby’s heart, lungs, blood, skin, liver & other organs.• Ability to self-multiply.• Body’s natural repair system.

SourcesSources

TypesTypes

• Umbilical cord blood largely contains Hematopoietic Stem Cells • Mesenchymal cells can be obtained from:

• Cord tissue

Residual blood in the baby’s umbilical cord after birth is cord bloodResidual blood in the baby’s umbilical cord after birth is cord blood It’s a high concentration of special type of cells called stem cells It’s a high concentration of special type of cells called stem cells

Importance of Cord Importance of Cord BloodBlood

Stemcell Cryo-BagStemcell Cryo-Bag

Cord Blood UsesCord Blood Uses

• Blood cancer• Thalassemia• Sickle Cell Disease• Inherited disorders• Stem Cell disorders• Platelet disorders• Immune disordersOVER 75 BLOOD DISORDERS

T-Cell Lymphoma

Importance of Cord Importance of Cord TissueTissue

Collection Tube with Cord Piece

Removal of Blood Vessels from Cord

Culture of MSC’s from Umbilical Cord

THERAPEUTIC POTENTIAL OF MESENCHYMAL STEM CELLS MSC’s(CORD TISSUE)THERAPEUTIC POTENTIAL OF MESENCHYMAL STEM CELLS MSC’s(CORD TISSUE)

• Over 50 clinical trials have been initiated worldwide using MSC’s to evaluate their safety and efficacy for treatment of diseases such as

– Graft vs. Host Disease Phase III– Crohn’s Disease Phase III– Juvenile Diabetes Phase II– Congestive Heart Failure Phase II– COPD Phase II– Articular Cartilage Defects Phase II – Acute Myocardial Infarction Phase II– Multiple Sclerosis Phase I / II

HistoryHistory

• In 20 years, applications increased from 1 to 75 life-threatening diseases.

• Over 15,000 successful transplants.

• 97 Cord Blood Banks in USA.

• 4 US states where CBB is mandatory.

New England Journal of MedicineNew England Journal of MedicineAdvancements in Cord Blood Stem Cells

1988 2006 2020

Diseases treatable with Cord Blood 1 75 ?

Number of cord blood transplants 1 6,000 ?

Number of families who banked cord blood - 400,000 ?

Odds of being diagnosed with a disease that is treatable with cord blood stem cells, by age 50

1 in 300,000

1 in 100 ?

The Vision for Stemcell Therapies for Neurological Disorders

Brain and spinal cord injury.

Stroke.Neurodegenerative diseasesParkinson’s Disease

Huntington’s DiseaseAlzheimer’s Disease

Multiple SclerosisLou Gerhig’s Disease (ALS)

Real case of Cord Blood Transplant?Real case of Cord Blood Transplant?

Has a bit of his brother inside him.

Has conquered Thalassemia,

March 2009 – A vital day

Apollo Hospital , Chennai

August 2005 Diabeties (type 1) Autologous Shands Hospital, Florida

August 2005 Anoxic Brain Injury AutologousDuke University Medical Centre North Carolina

September 2005 Paralysis Nephew Aguascalientes, Mexico

October 2005 Acute Myeloid Leukemia Sibling Chennai, India

January 2006 Neuroblastoma AutologousVanderblit University,

Tennessee

April 2006 Cerebral Palsy AutologousDuke university Medical center, North Carolina

May 2006 Diabeties ( Type 1 ) Autologous Shands Hospital, Florida

June 2006 ALL Sibling ISSSTE Hospital, Mexico

September 2006 Cerebral Palsy AutologousDuke university Medical Center, North Carolina

September 2006 Thalassemia SiblingSiriraj Hospital Medical

Center, Bankok

January 2007 Ischemic Brain InjuryAutologous Duke university Medical

Center, North Carolina

March 2007 Sepsis following Liver Transplant

Autologous Medical College of Virginia, Virginia

April 2007 Thalassemia MajorSibling

Sterling Hospital, Ahmedabad

May 2007 Thalassemia Major SiblingMount Elizabeth Hospital,

Singapore

October 2007 Thalassemia Major SiblingApollo Speciality Hospital,

Chennai

November 2007 Diabetes ( Type 1 ) Autologous Shands Hospital, Florida

December 2007 Neuroblastoma AutologousMedical City Children’s

Hospital, Texas

January 2008 Acute Myeloblastic Leukemia Sibling Hospital Juan I , Menchaca

June 2008 Cerebral Palsy AutologousDuke university Medical Center, North Carolina

August 2008 Sickle Cell Anemia Sibling North Shore Long Island Jewish Children’s Hospital

August 2008 Chronic Myeloid Leukemia Sibling Appollo Hospital, Chennai

February 2009 Thalassemia Major Sibling Duke University Medical Center, North Carolina

March 2009 Thalassemia Major Sibling Apollo Hospital, Chennai

ABOUT LIFECELL

Established in 2004, LifeCell is today India’s largest stem cell bank with presence in over 65 cities and with more than 35,000+ clients

Its quality systems have been accredited by organizations such as DGCI,ISO,AABB,CAP,USFDA,DSIR,Etc.

Dedicated stem cell company offering complete portfolio of services including R&D, Multi-Service Banking, Therapy, and Clinical Research

Technology partnerships with industry leaders such as Cryo-Cell International, and Harvest Therapeutics

• Lifecell International Private Limited—About the Promoter

• Lifecell has been promoted by the Promoter of Shasun Chemicals Limited(www.shasun.com), a Chennai based Rs.500 crore pharma & biotech company. Shasun is a widely respected company which has been in business since 1976, and is also listed on the NSE & BSE.

• Shasun has three facilities in India and two in UK.

THIRD PARTY LICENCES

• DRUG CONTROLLER OF INDIA ; Basic license for any cord blood bank operating in India.

• ISO 9001-2000 QUALITY STANDARDS by DNV

• AABB Accreditation : The first & only Stem Cell Bank with its facility in India accredited by AABB, USA to facilitate utilization of stored Stem Cells in other countries in the event of requirement.

• Certified by DSIR, Govt. Of India Endorsing High Credibility

It was a team of 7 Doctors from College of American Pathologists (CAP) to test and certify our quality practices. The accreditation certified is called “CAP – Accreditation “in terms of the authority on certification they provide on the Pathological Tests ,like Haematology, Microbiology, Serology and Flow Cytometry which ensures reliability of results and superior customer care.  The distinguished team had an interaction with the Heads of the department as well as the Technologists while scrutinising the Standard Operating Procedures, posters, safety and most importantly the competencies of the Staff as well as their continuous training.Now, the great news is that, the CAP Auditors were impressed with our quality of service and practices. 

US FDA Standards

The United States Food & Drug Administration (US FDA) is the largest governmental regulatory body responsible for the protection of public health. During the early years of cord blood banking, the only regulation that the FDA imposed was mandatory screening for certain diseases such as HIV. But since 2005, the US FDA has framed a full body of regulations outlining the procedures and methods that banks and laboratories must follow. These regulations cover the appropriate collection, processing, packaging, labeling and distribution of cord blood stem cells.In the United States, it is therefore mandatory for all cord blood banks to adhere to the FDA's regulations, which ensure the safe handling and storage of cord blood stem cells. And when a cord blood bank also has AABB Accreditation, it is further evidence of the bank's commitment to quality.

http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/EstablishmentRegistration/TissueEstablishmentRegistration/FindaTissueEstablishment/ucm110270.htm

Features of Lifecell International Pvt.Ltd.Features of Lifecell International Pvt.Ltd.

First Stem Cell Company who started the concept in India with Technology Partner Cryo-cell Inc. First Stem Cell Company to get ISO 9001-2000 certificate First Stem Cell Company to get the prestigious accreditation from AABB First Stem Cell company to get the DSIR recognition of In-House R&D Unit First Stem Cell Company to own its own Transplant & Clinical Trials Cenmte –TRICell First Stem Cell Company to get the prestigious registration USFDA CGMP & CGLP – Fitted with a central monitoring system which monitors Temperature, Humidity and Pressure.CGMP & CGLP – Fitted with a central monitoring system which monitors Temperature, Humidity and Pressure.

Class 100 Clean Room with 0.3 Micron HEPA FiltersClass 100 Clean Room with 0.3 Micron HEPA Filters Confirms to USFDA StandardsConfirms to USFDA Standards Unique LIMS to track samples after storageUnique LIMS to track samples after storage UN 3373 Certification for Collection Kit BoxUN 3373 Certification for Collection Kit Box 3 Unique ID’s for every sample stored ( Customer ID, Lab ID& Sample ID )3 Unique ID’s for every sample stored ( Customer ID, Lab ID& Sample ID ) Total Sample preserved 30,000+ We already provided 18 samples to our clients for the Transplant 5 Lac Insurance for Stemcell Transplant for the particular child anywhere in India 10 Lac will be provided in the event if the Stemcell not ingraft in the Body. Worldwide free retrieval NBS for 101+ Genetic Disorders

Process of Stem Cell BankingProcess of Stem Cell Banking

RegistrationKitBox

DeliveredCall 24*7 to Lifecell For Sample

Collection

Paramedic Staff Will Collect the Sample

Sample Despatch to Lab Through Bluedart/JetAirways

Processing of SampleReport Despatched after

45days