Private Bank /Public Bank LifeCell - “Community Bank”

LifeCell’s Community Banking - The Best Solution

to Meet the Recommendations, Challenges & Need of the Hour
Abides by the Recommendations of IAP & IMA
LifeCell's Community Stem Cell Bank works similar to a Public Bank. Parents contribute their baby's cord blood stem cells to a
common pool for use by themselves and other members of the community. This increases the chances of finding a suitable matching
donor and thereby expands the treatment options for patients. Thus, the Community Banking model completely meets the IAP and
IMA recommendations. Not only does Community Banking solve the challenges of low inventory and high costs of the public
banking model, it is also a more sustainable business model compared to public banks.
 Now Every Patient in India
Can Find Matching Stem Cells
for Treatment
LifeCell’s Community Bank now has an
inventory of over 25,000 qualified umbilical
cord blood units

Offers >96% probability of finding a suitable

stem cell match for patients of Indian origin

“ Welcome to the new era of stem cell banking where

not just the birth of a newborn that will be celebrated,
but also of that which comes attached to it at birth -
“
the umbilical cord!

Ayushmaan Bhava
 “ With high birth rate of close to 26 million a year,
India has potential to become an epicenter of
umbilical cord blood transplant (UCBT). Nearly
70% of patients of Indian origin who require
bone marrow transplantation do not find a
match within their own family. Hence, unrelated
umbilical cord blood (UCB) is a widely accepted
source of progenitors for HSCT. However,
to-date the total number of UCB transplants
performed in India has been very low mainly due
to high cost and limited number of UCB units
available against the estimated requirement of
over 50,000 units annually. For cord blood bank
to be effective, it should have at least 25,000
units and it shall then be able to provide a
matched cord for 96% of its patients.
“
Dr. Purvish M. Parikh
India's Leading Haemato-Oncologist
MD, DNB, FICP, PhD, ECMO, CPI, MBA
Director of Precision Oncology and Research,
Asian Cancer Institute, Mumbai, India.

Stem cells have immense potential in treatments and stem cells. With LifeCell's Community Stem Cell
every day we are witnessing enormous developments Banking, we have the opportunity to access, collect
of their therapeutic usage. I've personally handled and preserve those precious stem cells at birth.
numerous stem cell transplants in my experience as a Most parents assume that, their baby's preserved
haemato-oncologist. stem cells can protect the baby from all life-
threatening medical conditions. However, the
In spite of their potential in treating several life- baby's own stem cells can treat only about 10% of
threatening conditions, patients find it very the conditions and majority of the conditions
challenging to find matching stem cells for treatment. require stem cells from another person - a donor.
Many of them experiences endless waiting period and Therefore, a community model of banking makes
some even succumb to the disease; unable to find a greater sense for the family as well as the society at
suitable match. In India, public stem cell banks large. In a community bank, you become a member
function like blood banks and have only 6,500 stem by contributing your baby's umbilical cord blood
cell units available for therapeutic usage. These stem cells at the time of birth by paying one-time
numbers fall short in finding suitable matching stem processing fees for preservation. This sample then
cells or to serve the entire patient population. becomes part of the common community pool.
Additionally, another option to procure matching Whenever there is a need in the family, whether it is
stem cells comprises bone marrow registry, where a the baby, the sibling of the baby or the parents or
list of voluntary donors willing to donate stem cells grandparents, the common community pool can be
from their body is acquired. This list of bone marrow accessed to find matching units of stem cells for
stem cell donors is also trivial compared to the treatment at no additional cost and any number of
requirement. This shortcoming is further times.
complimented with prospective donor backout due to
surgical procedure. Therefore, if you are expecting a baby, remember,
there is only one opportunity in life to get the
With a baby's birth, nature gifts the entire family a protection of stem cells, for the baby and your
valuable resource in the form of umbilical cord blood entire family. Preserve it wisely!

01
 RECOMMENDATIONS
Umbilical Cord Blood Banking: Consensus Statement of the Indian
Academy of Pediatrics.
1 2 3 3 4 5 6 7 4
Sachdeva A , Gunasekaran V , Malhotra P , Bhurani D , Yadav SP , Radhakrishnan N , Kalra M , Bhat S , Misra R ,
8
Jog P ; For the ‘Guidelines on Umbilical Cord Blood Banking’ Committee of Indian Academy of Pediatrics.

From
1 Sir Ganga Ram Hospital, New Delhi, India. Correspondence to: Dr. Anupam Sachdeva, Director, Pediatric
Hematology Oncology and Bone Marrow Transplantation unit, Institute of Child Health, Sir Ganga Ram
Hospital, New Delhi 110 060, India. [email protected].
2 Sir Ganga Ram Hospital, New Delhi, India.
3 Rajiv Gandhi Cancer Institute and Research Centre, New Delhi, India.
4 Medanta - The Medicity, Gurugram, India.
5 Super Speciality Pediatric Hospital and Post Graduate Teaching Institute, Noida, India.
6 Indraprastha Apollo Hospitals, New Delhi, India.
7 Narayana Health City, Bangalore, India.
8 DY Patil Medical College, Pune, India.

JUSTIFICATION: Practitioners and people need information about the therapeutic potential of umbilical cord
blood stem cells and pros and cons of storing cord blood in public versus private banks.

PROCESS: Indian Academy of Pediatrics conducted a consultative meeting on umbilical cord blood banking
on 25th June 2016 in Pune, attended by experts in the field of hematopoietic stem cell transplantation
working across India. Review of scientific literature was also performed. All expert committee members
reviewed the final manuscript.

OBJECTIVE: To bring out consensus guidelines for umbilical cord banking in India.

RECOMMENDATIONS: Umbilical cord blood stem cell transplantation has been used to cure many malignant
disorders, hematological conditions, immune deficiency disorders and inherited metabolic disorders, even
when it's partially HLA mismatched. Collection procedure is safe for mother and baby in an otherwise
uncomplicated delivery. Public cord blood banking should be promoted over private banking. Private cord
blood banking is highly recommended when an existing family member (sibling or biological parent) is
suffering from diseases approved to be cured by allogenic stem cell transplantation. Otherwise, private cord
blood banking is not a 'biological insurance', and should be discouraged. At present, autologous cord stem
cells cannot be used for treating diseases of genetic origin, metabolic disorders and hematological cancers.
Advertisements for private banking are often misleading. Legislative measures are required to regularize the
marketing strategies of cord blood banking.

KEYWORDS: Hematopoietic stem cell transplantation; Hybrid ode; Guidelines; Umbilical cord.
Ref: Sachdeva A, Gunasekaran V, Malhotra P, Bhurani D, Yadav SP, Radhakrishnan N, Kalra M, Bhat S, Misra R, Jog P.
Umbilical Cord Blood Banking: Consensus Statement of the Indian Academy of Pediatrics. Indian Pediatrics, Vol 55, June 15, 2018

“ The Indian Academy of Pediatrics (IAP) and the Indian Medical Association (IMA) have recently
issued recommendations against private banking of umbilical cord blood. They argued that the
chance of a baby using its own stem cells is "negligible". Hence, both the IAP and IMA recommend
that families in India should preserve their baby's cord blood in public banks rather than in private
banks. LifeCell's Community Stem Cell Bank works similar to a Public Bank and it not only solves
the challenges of low inventory and high costs of the public banking model but is also a more
“
sustainable business model compared to public banks.

02
Pool Banking Ensures Effective Use of Umbilical Cord Blood Stem Cells:
Experts
With a high birth rate of close to 26 million a year, India has a potential to become an epicenter of UCBT.
Despite this, with less than 5,000 units in the public banks, only 32 cord blood transplants have taken place in
the country.
By: BioVoice Correspondent - August 29, 2018

New Delhi: Doctors have an advice for parents who are considering umbilical cord blood banking for their
newborns. They suggest that parents should consider pool banking, which allows access to each other’s cord
blood unit when needed.

“This is because in most blood-related disorders Umbilical Cord Blood Transplant (UCBT) is recommended
to be that of another person (allogeneic) and not your own (autologous), as the genes which caused the
disorder, are present in the cord blood, and so for the treatment you require a healthy cell and not the mutant
one,” says Dr Rahul Bhargava, Director, Haematology, and Bone Marrow Transplant, at Fortis Memorial
Research Institute, Gurgaon.

“ Stem cell transplant experts said that, parents who are considering umbilical cord blood banking for
their newborns consider Pool Banking, which allows access to each other's cord blood unit when
needed. Due to lack of knowledge, expectant parents generally don't know what is best for them
while privately banking their baby's cord blood unit.
“
03
Cut Pvt. Umbilical Cord! Experts Bat for National Bank
Monday, 08 October 2018 | SUGANDHA | NEW DELHI

With a few public cord blood banks in India, private cord banking is a waste of time, effort and money, unless
viable samples are donated, suggest experts, calling for setting up of National Cord Blood Bank on the lines of
blood banks in India.

A cord blood bank is a facility which stores umbilical cord blood for future use in treating diseases of the
blood and immune systems.

Highlighting the system of cord blood banking in the country, Dr. Geeta Jotwani, Deputy Director General,
Indian Council of Medical Research (ICMR) and National Coordinator for Stem Cells Study said, "In India,
the scenario is that there are private cord blood banks, there is no Government initiative. There were plans to
make a National Cord Banking System in India by the Government sometime back but the whole thing ended
with reasons unknown to us."

Terming the private cord banking systems to be ‘a marketing gimmick’, Dr Rahul Bhargava, Director,
Haematology, and Bone Marrow Transplant, at Fortis Memorial Research Institute, Gurugram, said, “When
people thought that they can cure any disease with the help of stem cells, they were wrong. It can only be used
in some hematological disorders and bone marrow transplants. Moreover, if your child is born with a
disorder, the same gene cannot be used to cure it because it is already deformed. Unfortunately, there is no
decline in the demand as a marketing gimmick is going on.”

“ “Unfortunately, privately stored units have not helped to reduce the huge burden of hematological
disorders in India that come within the scope of treatment using a cord blood stem cell unit. This is
because all of these units have been preserved for self-use which renders the banked cord blood
unit in most cases unusable,” says Dr. Satya Prakash Yadav, Director – Paediatric Hemato Oncology
& Bone Marrow Transplant, Medanta, Gurugram.

Dr. Rahul Bhargava - Director and Head of Haematology, Haemato-Oncology and Stem Cell
Transplant at Fortis Memorial Research Institute, Gurugram says “The chance of a baby later
benefiting from his or her own privately banked cord blood is currently less than 0.04 percent,
according to the ASBMT. The child’s own cord blood would be unusable in most blood conditions
because those stem cells contain the same genetic defects and so for the treatment you require a
healthy cell. Storing cord blood of newborn, which otherwise is routinely discarded, in a POOL
BANK, may help treat a large number of patients with blood-related diseases.”
“
04
LifeCell’s Community Cord Blood Banking Aligns with Recommendations
of India’s Medical Bodies
July 2018 - Vinesh Mandot

Recommendations of India’s Medical Bodies

Recently, two important professional associations of doctors in India have issued

statements against private banking of umbilical cord blood. Both the Indian
Academy of Pediatrics (IAP) and the Indian Medical Association (IMA) have
argued that the chance of a baby using its own stem cells is “negligible”. Both
medical opinions consider allogeneic stem cell transplants to be the only valid use
of cord blood, and only consider those diseases treated with transplants from a
donor.
1,2
Hence, both the IAP and IMA recommend that families in India should preserve
their baby’s cord blood in public banks rather than in private banks. A public cord
blood bank is a common pool of stem cells, where patients in need can readily find
matching stem cells for treatment In India.

Challenges faced by Public Cord Blood Banks in India

Low Inventory:

3,4
Ÿ The total inventory of purely public cord blood units in India is below 6,500 CBU
Ÿ Jeevan, the only public bank that lists Indian cord blood units for transplant, has stopped to accept further
4.
cord blood donations due to lack of funds
3
Ÿ Globally, there are about 7,50,000 public CBU spread over 55 major public banks in the world . But the
ability to find a donor that is a close enough match for transplant depends on ethnicity, and calculations
4
show that the chance of an Indian finding a match from these global cord blood banks is less than 10%

High Cost:

5
Ÿ Currently the cost to procure a single public cord blood unit in India is INR 15-20 lakhs
Ÿ The cost to procure a public CBU from abroad varies by bank but is typically INR 30 lakhs
Ÿ An adult patient may require two CBU for a transplant, doubling the cost
Ÿ Additional expenses, such as hospital costs, might accrue to INR 15-20 lakhs

Ref: https://parentsguidecordblood.org/en/news/lifecells-community-cord-blood-banking-aligns-recommendations-indias-medical-bodies

“ LifeCell's Community Banking model resolves the country's dearth of stem cell assets by making
available large number of cord blood units for patient's immediate use. This is the only stem cell
banking model that can provide protection for the entire family against all the conditions treatable
using stem cells. LifeCell will take earnest efforts to scale this up and forsees the day not too far
from now when every patient will have a fully matched unit available.
“
05
Doctor’s Voice

“Likelihood of using own cord blood is very small (less than 0.04%). Hence, the donation of cord blood
to public bank is recommended because there is 100 times more likely chance of release of a unit from
public bank compared to a private bank. - Recommendations by ACOG, AAP and ASBMT.

In majority of blood disorders, the child's own stored cord blood cannot be used for the same
child as they will carry the same genetic defect. - Padma Shri Dr. K. K. Aggrawal, Immediate Past
President of Indian Medical Association (IMA)- April, 2018.

According to the current literature, Community Banking is better than Private Banking. - Dr. Ashima
Taneja, MD (Obst & Gyanec), Dayanand Medical College and Hospital, Ludhiana, Punjab.

Community stem cell banking is really a need of this era and please make sure to take this idea especially
to remote areas. - Dr. Yogita Chandarvanshi, Senior Consultant and Medical Director of Chandrayan
Health Care, Raipur, Chhattisgarh.

Dr. Niranjan N Rathod, Associate Director & Head of Department, Haemato-Oncology & Bone Marrow
Transplant, Nanavati Super Speciality Hospital, Mumbai said, "We have a huge number of patients
suffering from fatal blood disorders like Blood Cancer and Thalassemia Major for whom the last resort
is a Blood Stem Cell transplant. For patients who could not find a match within their family there was no
hope. It is only with help of unrelated donor registries that there is a ray of hope for such patients.”

Private banks continue storing umbilical cords, with no one questioning its futility. This kind of singular
banking systems is reaping little gain but with the general lack of awareness, parents are falling into deep
traps. The reserves should be turned into pools of sharing resource. Patients can be treated by choosing
the closest match from the available pool. - Dr A. Kannan, Head of Paediatrics, Meenakshi Mission
Hospital, Madurai, Tamil Nadu.

Routine non-directed cord blood and cord banking as a form of 'biological insurance' against future
disease should be discouraged. Restructuring the way umbilical cord blood is stored and shared will
present new paradigms of treatment. Filling the large gap between what's available and what's usable is
now the need of the hour. - Dr. Prathima Reddy, Senior Obstetrician and Gynaecologist, Director of
Fortis La Femme Hospital, Bangalore, Karnataka.

Being in this field for almost 17 years people do turn up to me for suggestions regarding the option of
saying "yes" or "no" to cord blood banking. I am definitely in a better position to say YES to them after I
heard about your Community based cord blood banking program. It is unfortunate that our country
lacks the awareness about cord blood banking and the ones who know a little about it are sceptical to go
for it. Nevertheless, our country is in the "willing to learn" category and I am sure in the next few years
most of the pregnant mothers will be opting for cord blood banking, hopefully all of them with LifeCell.
- Dr. Praveen Clement, Transplant Coordinator, Marrow Donor Registry India (MDRI)
“
06
07
Why Choose Community Bank Over Private Bank?
By choosing community banking, you unbox 80 times greater potential of your baby's stem cells through
unmatched benefits such as protection from all conditions treatable by stem cells, complete family
protection, unlimited number of retrievals at no additional cost.

Nature gives a once-in-a-lifetime opportunity. Choose wisely!

08
 Lifecell’s Community Banking - The Best Solution
to Meet the Recommendations, Challenges & Need of the Hour

Bigger inventory of Indian origin samples

increases the chance of finding match
• As per ICMR, the chances for an Indian to
find minimum matching unrelated cord
blood donor in a bank is over 95% with
an inventory size of 50,000 samples6
• LifeCell’s Registry currently has
over 25,000 qualified cord blood
samples (3X of all public banks in
India)
• It is estimated that by
2022, LifeCell will have
sufficient inventory to
provide a well
matched unit to almost
all of its community
members and their families

Exclusive Benefits of LifeCell Community Banking

• Complete Protection to the Baby against all conditions treatable using stem cells (own & donor)
• Protection to the baby's siblings, parents and grandparents with unrelated donor stem cells
• Exclusive access to LifeCell Registry for the baby and its family (3x than any public bank in India)
• Unlimited Financial Assistance of INR 20 lakhs for every transplant for the baby, siblings & parents
• Coverage for Bone Marrow or Peripheral Blood Stem Cells Transplant of INR 20 lakh for every transplant
for the baby, siblings & parents
• Continued protection of stem cells to the baby and its family even if the baby’s cord blood is of low volume
or unfit for processing / storage
• Full Money Refund (except sample collection charges) if your baby’s cord blood is used by another LifeCell
community member. Your entire family continues to enjoy the benefits of community banking till the baby's
entire lifetime
• Free of Cost HLA Typing using NGS (Next Generation Sequencing) for the baby, siblings, parents and
grandparents (maternal & paternal)

09
Apartim's Story: Autism Treatment with Own Cord Blood Preserved
at LifeCell - (July 2017)

Apartim Dey Singha of Kolkata, India, is now four years old.

Although his birth was a month premature, as an infant he passed all
his developmental milestones on time. It was not until he reached 18
months of age that his parents noticed his communication skills
were not progressing like other children. "We were worried but our
local pediatrician was positive. He asked us to observe him for
another six months. We saw no changes in his behaviour." - Apurba
Dey Singha, Apratim's father. Apratim saw a specialist in Delhi who
diagnosed him as having Autism Spectrum Disorder (ASD). Autism
refers to a range of conditions characterized by challenges with
social skills, repetitive behaviors, speech and nonverbal
communication, as well as by unique strengths and differences. Each
person with autism presents differently, but has enough of the traits
to be recognized as being on the spectrum. Apratim's family researched interventions to improve his language
skills and tried several approaches. They learned that in 2014, the same year Apratim was born, Duke
University launched the first in a series of clinical trials treating autism with cord blood stem cells. Results
from the first Duke trial of cord blood therapy for autism were published open access in April 2017. In that
pilot study, participants showed significant improvements in measures of social skills, expressive vocabulary,
severity of autism behavior patterns and eye-tracking response to stimuli. The children's scores were
measured by both parents and clinicians using established behavioral scales developed for autism. The
observed improvements appeared within 6 months of cord blood therapy. In a press release from Duke
University, lead investigator Dr Joanne Kurtzberg expressed “cautious optimism” but urged parents not to
jump to conclusions: "Parents of children with autism should not interpret these results as conclusively
showing effectiveness of this treatment. There is much work still to be done in much larger, randomized
clinical studies before we can draw any firm conclusions about effectiveness." - Joanne Kurtzberg, MD.
Apratim's cord blood had been stored since birth with LifeCell International, the largest family cord blood
bank in India. His parents asked to participate in a clinical trial at Duke, and after a number of tests he was
accepted. The therapy took place in the United States in July 2017. In the 9 months since the cord blood
therapy, his father says he has seen significant changes in Apratim. He is communicating more, his cognitive
skills have improved, he's started school, and he likes playing with his friends. “We were happy that we made a
wise decision of preserving our baby's umbilical cord stem cells at birth in 2014 with LifeCell, which were
used to treat my son for autism. Today, we are seeing great progress in terms of development milestones in my
son." - Apurba Dey Singha.

10
Effect of Autologous Cord Blood Infusion on Motor Function
and Brain Connectivity in Young Children with Cerebral Palsy:
A Randomized, Placebo-Controlled Trial
Ref: Sun JM, Song AW, Case LE et al. Effect of autologous cord blood infusion on motor function and brain
connectivity in young children with cerebral palsy: A randomized, placebo-controlled trial. Stem Cells
Translational Medicine 2017;6:2071–2078.

Abstract
Cerebral palsy (CP) is a condition affecting young children that causes lifelong disabilities. Umbilical cord
blood cells improve motor function in experimental systems via paracrine signaling. After demonstrating
safety, we conducted a phase II trial of autologous cord blood (ACB) infusion in children with CP to test
whether ACB could improve function (ClinicalTrials.gov, NCT01147653; IND 14360). In this double-blind,
placebo-controlled, crossover study of a single intravenous infusion of 1-5 × 107 total nucleated cells per
kilogram of ACB, children ages 1 to 6 years with CP were randomly assigned to receive ACB or placebo at
baseline, followed by the alternate infusion 1 year later. Motor function and magnetic resonance imaging
brain connectivity studies were performed at baseline, 1, and 2 years post-treatment. The primary endpoint
was change in motor function 1 year after baseline infusion. Additional analyses were performed at 2 years.
Sixty-three children (median age 2.1 years) were randomized to treatment (n = 32) or placebo (n = 31) at
baseline. Although there was no difference in mean change in Gross Motor Function Measure-66 (GMFM-
66) scores at 1 year between placebo and treated groups, a dosing effect was identified. In an analysis 1 year
post-ACB treatment, those who received doses ≥2 × 107 /kg demonstrated significantly greater increases in
GMFM-66 scores above those predicted by age and severity, as well as in Peabody Developmental Motor
Scales-2 Gross Motor Quotient scores and normalized brain connectivity. Results of this study suggest that
appropriately dosed ACB infusion improves brain connectivity and gross motor function in young children
with CP. Stem Cells Translational Medicine 2017;6:2071-2078.

“ “
"Out of the 63 children who participated in this clinical trial in the US, 5 children were from India
whose parents had banked their cord blood stem cells at birth with LifeCell; which turned out to be
life saver for the kids!"

11
How Long Can Cord Blood be Cryopreserved?
6th November 2018

“Yesterday we shipped a cord blood unit that was collected

and banked exactly 20 years ago. As I write this, the frozen
unit should be just arriving at the Cell Therapy Laboratory
on the other side of the world, where it will soon be thawed
and infused into the young girl waiting in hospital to
receive the new blood stem cells which will hopefully cure
her leukaemia. Prior to shipment of the cord blood unit we
tested a sample of the cells; even after 20 years of being
stored at -196 degrees celsius, 99.4% of the cells were
recovered, with a stem cell viability of 87%. Beautiful!
Recently I was asked the question of why, when we release
only a small number of cord blood units each month, do we
need to keep collecting cord blood. Public unrelated cord
blood banking is not a matter of one in and one out; it is all
about being able to provide choice and having exactly the
right tissue typing match and cell make up for a patient at
their time of need, whatever their ethnic background. I am
the Director of the BMDI Cord Blood Bank in Melbourne,
which is run as a partnership between the Murdoch
Childrens Research Institute, the Royal Childrens Hospital
and the Fight Cancer Foundation, working closely with the
Australian Bone Marrow Donor Registry and the two other AusCord Cord Blood Banks in Australia. Federal
and state governments fund our operations, along with generous financial support over the years from
philanthropic organisations. The Cord Blood Bank is licensed for cell manufacturing through the Therapeutic
Goods Administration (TGA) and is internationally accredited through the Foundation for the Accreditation
of Cellular Therapy (FACT). The compliance of our operations with these regulatory authorities ensures that,
even 20 years down the track, we are providing a therapeutic product of the highest quality to ensure that
patients are given the best chance of a successful outcome. It takes a team of people to bring this end result,
from the generous and altruistic cord blood donors, the collection, production, transplant and quality staff
within the bank, our testing labs and the infrastructure and support of our host institutions. Next week on
November 15th around the globe we will be celebrating World Cord Blood Day. During that same week a
family will be celebrating the 20th birthday of their son. Privacy rules do not allow us to tell that family that
the gift they so generously made as they were celebrating the new birth in their family, is this week providing
the hope of new life to another. This is why we do what we do.”- Director, BMDI Cord Blood Bank,
Melbourne.

“ Cord blood donated 20 years ago in at the BMDI Public Cord Blood Bank, Melbourne, Australia has
been shipped to the other side of the world at Cell Therapy Laboratory, USA where it is being
prepared for infusion in a young girl who is waiting in a hospital to receive new blood stem cells
that will hopefully treat her leukemia. Even after 20 years, 99.4% of the cryopreserved cells were
recovered, with a stem cell viability of 87%, according to the Director of the bank from which the
unit was shipped.
“
12
LifeCell International Private Limited
#26, Vandalur Kelambakkam Main Road,
Scan me to locate
Keelakottaiyur, Chennai - 600127.Tamil Nadu India.
LifeCell Centre
near you
TOLL FREE: 1800 266 5533 | SMS ‘LIFECELL’ to 53456
www.lifecell.in