OCT 2004 Nietfeld & Verter 1
Statistics of AutologousCord Blood Storage and Use
J.J. Nietfeld, Ph.D.University Medical Center
Utrecht, The Netherlands
Frances Verter, Ph.D.www.ParentsGuideCordBlood.com
OCT 2004 Nietfeld & Verter 2
Contents
• Introduction to authors• Review of cord blood industry• Inventory of stored cord blood in USA• Previous opinions and estimates re usage• Calculate lifetime probability of
autologous transplant• Forecast lifetime probability of autologous
use for regenerative medicine• Implications
OCT 2004 Nietfeld & Verter 3
J.J. Nietfeld, Ph.D., Biography
• Biochemist & Pathobiologist• Associate Professor, UMC Utrecht, The Netherlands• P.I. 2003 ZonMw report:
“Desirability and feasability of a Personal Cell Bank”
Netherlands Report proposes 3-way split of storedcord blood: 1- private portion 2- public portion 3- research portion
OCT 2004 Nietfeld & Verter 5
ParentsGuideCordBlood.com
• Mission Statement:
Impartial review of cord blood storage options
How To use website Public Bank List
Medical motives for storage Private Bank List
Diseases Treated by SCT Types of banks
Research Regulations by nationality
News reports Lab processing
Ethical & Legal Issues Suggested Questionnaire
Cost & Reimbursement Summaries & Prices
OCT 2004 Nietfeld & Verter 6
Website Readership
– Hits from over 70 foreign countries in the past month
– Average monthly hits over past year: 158,933
67,494 = 36.03 % .net 38,656 = 23.51 % .com 38,590 = 21.20 % (numerical IP) 3,837 = 2.85 % .br (Brazil) 4,338 = 2.81 % .edu (USA Edu) 1,930 = 1.24 % .org (Non-Profits) 2,140 = 1.19 % .de (Germany) 1,938 = 1.06 % .ca (Canada) 1,942 = 1.05 % .au (Australia) 2,468 = 1.03 % .mx (Mexico) 14,716 = 8.03 % ALL OTHERS
OCT 2004 Nietfeld & Verter 7
Types of Cord Blood Banks
Private bank
Transplant
public bank
Research
public bank
Parent cost $900-$1800 Free Free
Blood owner
Parents Bank Bank
Bank income
Parents Med. Ins.
& Sales
Sales &
Patents
Blood usage
Parental
discretion
Transplants
& Research
Research
OCT 2004 Nietfeld & Verter 8
USA Cord Blood Inventory
NUMBER 9/2003 9/2004 + %
Private CB Banks 15 21 40%
Public CB Banks 18 20 11%
# private customers 179,350 > 270,991 55%
# public donations
NMDP + NYBC alone
58,650
49,000
> 76,145
59,325
21%
# private CBT's 55 to date 71 to date 29%
OCT 2004 Nietfeld & Verter 9
Investments in CB Banking
$ 8 M NMDP 2004 infusion to cord blood banking
$ 9 M National Cord Blood Program year 1 funding
$ 75 M CBR investment in new building over 5 years
OCT 2004 Nietfeld & Verter 10
Previous Opinions Against Autologous Cord Blood Banking
• American College of Ob and Gyn (ACOG) 1997; Int J Gyn Ob, 58(2):257-259• American Academy of Pediatrics July 1999; Pediatrics, 104:116-118• Royal College of Ob and Gyn Oct. 2001; Opinion Paper 2• European Group on Ethics in Science and
New Technologies March 2004; Opinion No.19
OCT 2004 Nietfeld & Verter 11
Previously Published Chancesfor Autologous Transplant Use
• 74 : 200,000 (< 20 yrs) F.L. Johnson, 1997; J Ped Hem Onc 19(3): 183-186. (based on statistics of diseases and treatments)
• 1 : 20,000 ( < 20 yrs) G.J. Annas, 1999; NEJM 340: 1521-1524.
(not substantiated)
• 1 : 10,000 – 1 : 200,000 (lifetime) R.M. Kline, April 2001; Sci Amer 4: 30-37. (not substantiated)
OCT 2004 Nietfeld & Verter 12
Lifetime storage of Cord Blood:source of autologous stem cells
• At – 196 °C it takes thousands of years for
cosmic radiation to damage cells • Cord Blood Transplants on adults have
been successful in clinical trials• Numerous companies are “expanding” cord
blood cell counts• Current research focus is speeding cord
blood engraftment
OCT 2004 Nietfeld & Verter 13
Probability of an autologous transplant during one’s lifetime
P is a function of n and p
Where:
n = maximum age for treatment
p = probability / year of autologous transplant
The probability P depends on a formula which the authors wish to reserve until it is published.
OCT 2004 Nietfeld & Verter 14
Data for North America 2002
Transplants (Ref: CIBMTR) Number
Autologous Blood & Marrow 10,500
Allogeneic Blood & Marrow 7,200
Population Number
USA 288,000,000
Canada 31,000,000
Total 319,000,000
Population minus those over 70 290,000,000
OCT 2004 Nietfeld & Verter 15
Autologous Transplant Lifetime Odds: North America 2002
Probability P = 0.25%
Using
n = maximum age for treatment = 70
p = probability / year of autologous transplant
= (# autol. transplants per year) / (population < 70)
= (10,500)/(290 million)
OCT 2004 Nietfeld & Verter 16
Autologous Transplant Lifetime Chances up to age 70
Ch
ance
in
%
0
0.05
0.1
0.15
0.2
0.25
0.3
NorthAmerica
9 EUcountries
Netherlands
Geographic Area
Chance / life
OCT 2004 Nietfeld & Verter 17
Forecast of cord blood use for regenerative medicine
• Given long “shelf life” of cord blood, today’s babies can use autologous cord blood for future regenerative medicine
• Auto CB carries advantages over Auto BM:– Stem cells have more “plasticity” (under study)– No surgical harvest– Lower cost (depending on storage time)
• Lifetime probability of diagnosis gives an UPPER LIMIT for treatment
OCT 2004 Nietfeld & Verter 18
Example: autologous stem cells for Cellular Cardiomyoplasty
ie: stem cell transplantation for cardiac repair.
Indications: Myocardial Infarction,CongestiveHeart Failure
OCT 2004 Nietfeld & Verter 20
Cellular Cardiomyoplasty Lifetime Odds: USA 2001
Probability P = 14%
Example: USA inpatient PCI up to age n=75
Yearly rate p = (571,000/ 264,818,014) = 0.002
(Ref: American Heart Association Statistics)
OCT 2004 Nietfeld & Verter 22
Implications
• Autologous cord blood storage outnumbers
public donations and is growing faster.
• USA National Cord Blood Program will invest less $$ towards growth than private companies.
• Correct probability of autologous stem cell use is much higher than standard assumptions.
• Regenerative medicine dramatically increases opportunities for autologous use of stem cells.
• Private cord blood banking is here to stay.
OCT 2004 Nietfeld & Verter 23
Future: harness private inventory for public good?
• Need 150,000 CB for all USA transplants (Ref: Pablo Rubinstein, M.D., NYBC)• Private banks will add that much to
inventory in less than 2 years.• Instead of the USA government funding a program of public banks ---• Why not offer parents in private banks a REGISTRY OPTION? (with quality standards)