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Cord Blood Banking Standards in
India
Dr. Saranya Narayan M.D.
Medical Director
Jeevan Blood Bank & Cord Blood bank
www.bethecure.in
ACBS - 03/03/2013
Jeevan Blood Bank
• 17 year old not for profit organisation - 1995
• ISO Certified since 1999
• NABH ACCREDITED since 2010 May
• Jeevan Cord Blood Bank – 2007
• ISO 9001 - 2000 certified since 2008
• Several of our processes in the stem cell lab
– NABH accredited.
• EQAS participation covers most of the
processes
Regulatory Framework
DCGI
GUIDELINES -
ICMR
Certifying /
Accrediting
agencies
CORD BLOOD
BANK
INDIAN SCENARIO
Scope of the Guidelines
• Registration - Informed consent
• Cord Blood Collection
• Screening tests
• Quality assurance and control procedures
• Documentation
• Donor privacy
• Traceability
• Standard Operating Procedures
Licensing Scope
A. General Requirements – Location, premises
B. Cord Blood (CB)– Collection, transport and storage
C. Personnel
D. Air Handling system
E. Quality Control
F. Screening tests
G. Storage
H. Reference samples
I. Labeling
J. Records / Documentation
K. CB release
Certifications & Accreditations
Certification
ISO
Accreditation
National – NABH / NABL
International - AABB & Netcord
Comparison of Standards (1)
AABB NETCORD INDIA JCBB
ID Screening Maternal Maternal and Cord Blood Maternal Maternal and CB
HBV, HCV, HIV,HTLV,
CMV, Syphilis, BACT &
FUNGAL CULTURE
HBV, HCV, HIV, HTLV, CMV,
SYPHILIS + any locally
applicable tests, BACT &
FUNGAL CULTURE
HBV, HCV, HIV, HTLV, CMV,
SYPHILIS, MALARIA, BACT
& FUNGAL CULTURE
HBV, HCV, HIV, HTLV, CMV,
SYPHILIS , MALARIA, BACT
& FUNGAL CULTURE
CB - Viability > 90 %
CB - Recovery > 85 %
CB -
Hemoglobinopathy
screening
Sample obtained from
allogeneic donor or after
processing
To be done prior to release for
all allogeneic units
Can be outsourced - prior o
release
Sample obtained at the end of
processing
CB - HLA Typing A , B, DRB1 - molecular
typing
A, B, C, DRBI, & DQB1 -
molecular typing. DRB1 – High
Res typing a must prior to
release
Can be outsourced - prior o
release
Class 1 and Class 2 – Low /
Enhanced Res Molecular typing,
High Res outsourced prior to
release for unrelated allogeneic
CB - CFU Prior to release At storage and prior to release Outsourced - prior to release.
Being standardised
Comparison of Standards (2)
REFERENCE
SAMPLES
Maternal serum /
plasma NA
2 vials of serum or non
heparinised plasma stored in
cryo-vials at minus 20 0 C or
lower
NA
1-2 vials of serum or non
heparinised plasma stored in
cryo-vials at minus 20 0C or
lower
Maternal DNA NA Material sufficient for at least 50
ug DNA stored NA To be started shortly
CB - Viable cells
2 segments attached to the
bag frozen at -1960 C for
confirmatory HLA typing /
other tests
2 segments EACH of 100 ul must
be frozen at -196 0C for
viability,CFU& HLA TYPING
2 Segments at - 196 0C & one at
-700 C or lower
3 segments attached to the bag
must be frozen at -196 0C for all
required tests such as Counts,
Viability, Confirmatory HLA
typing, & CFU
2 segments each containing 1 x
106 cells . One for viability stored
at -196 0 C and for tests other
than viability at -70 0 C or lower.
1 (last) segment attached to the
bag to be issued to the transplant
centre with the CBU.
CB DNA Sufficient to extract 50 ug DNA Sufficient to extract 50 ug DNA
CBU on release
One segment should be attached
to the CBU at time of shipment
to transplant centre.
AABB NETCORD INDIA JCBB
Storage endpoints
• The final product must have > 90% viability with > 600x106 total nucleated cells.
• Final cell concentrations can range between 28-160 x 106/ml in final volume (~25ml) in cryopreservation bag.
CCBB SOP
• Jeevan – Upward of 28 x 106 /ml ( ~25 ml)
Online Search Facility
Our journey so far…
• Units stored : Close to 600
• Requests received : 4 – 5 / week
• Matches 4/6 and above - 4
• Transplants –2 ( Sibling donor )
The Road ahead…..
To step up Jeevan’s inventory to
5000 before Sept 30th 2014
“When we do the best we can, we never
know what miracle is wrought in our life,
or in the life of another.”
Helen Keller
