Clinical Trials with Cord Blood

Table 1. Clinical Trials where children use their own (autologous) Cord Blood Stem Cells


Diagnosis Occurence in USA Trial stage Trial registry
Acquired Hearing Loss 12.5% ages 6-19 phase 1 NCT01343394
NCT02038972
Autism 1.5% (1 in 68) children phase 2
phase 1
NCT01638819
NCT02176317
Cerebral Palsy 0.2% full term births,
2.2% premature births,
1 in 300 kids ages 5-10
phase 2 NCT01147653
NCT01072370
NCT01988584
pending
Hypoplastic Left Heart Syndrome 0.2 per 1000 births phase 1 NCT01445041
NCT01856049
Neonatal Oxygen Deprivation 0.2% full term births phase 1 NCT00593242
NCT01506258
Traumatic Brain Injury 435,000 per year ages 0-14
#1 cause of death in kids
phase 1 NCT01251003
NCT01700166
Type 1 Diabetes 1.7 per 1000 ages birth-19 phase 1 & 2 NCT00989547
NCT00873925
CoRD
Table copyright Frances Verter, PhD 2014 - References Below


Table 2. Clinical Trials using donor (allogeneic, includes siblings) Cord Blood Stem Cells


Diagnosis Occurence in USA Trial stage Trial registry
Cartilage Repair 10-25% adolescents
have knee injuries
Approved by
Korean FDA
(Cartistem)
NCT01733186
Cerebral Palsy 2 per 1000 full term births phase 2 NCT01193660
NCT01528436
NCT01639404
NCT01991145
NCT02025972
Critical Limb Ischemia 2.5 per 1000 people,
over 80% of them diabetics
phase 1 NCT01019681
Premature Lungs (BPD) 25% births under 1500gm phase 2 NCT01897987
Type 1 Diabetes 1.7 per 1000 ages birth-19 phase 2 NCT01350219
NCT01996228
Table copyright Frances Verter, PhD 2014 - References Below



References

Autism
Statistic 1 in 68 children are on the spectrum of autism related disorders is prevalence from CDC.
Cartilage Repair
Statistics on occurance from Louw et al. Brit. J Sports Med 2008;42(1)2-10 doi:10.1136/bjsm.2007.035360
News report on Cartistem approval
Cerebral Palsy
Statistic 2 per 1000 full term births is incidence rate from Centers for Disease Control (CDC)
Statistic 2.2% of premature births from
van Haastert IC et al. Pediatrics 2011; 159(1):86-91 doi:10.1016/j.jpeds.2010.12.053
Statistic 1 in 300 children ages 5-10 is prevalence from CDC.
Sun, JJ et al. Transfusion Sept. 2010; 50(9):1980-1987 doi:10.1111/j.1537-2995.2010.02720.x
Papadopoulos, K et al. Restorative Neurology and Neuroscience 2011; 29:17-22 doi:10.3233/RNN 20110572
Purandare C et al. 2012; Case Rep. Trans. 2012; Article ID825289, 6 pages doi:10.1155/2012/825289
Critical Limb Ischemia
Statistics on occurance from Bitar, FG & Garcia, LA Vascular Disease Management 2010;7:E182-E184
Hearing Loss (cord blood trial is for acquired sensorineural type)
Statistics on 1 per 1000 births with bilateral sensorineural hearing loss of at least 40 dB from
Smith, RJH, Bale Jr, JF, & White, KR. Lancet 2005; 365:879-90 doi:10.1016/S0140-6736(05)71047-3
Statistic: 12.5% of children ages 6-19 (5.2 million) suffer noise-induced hearing loss.
Niskar AS et al. JAMA.1998;279:1071-1075. AAP publications
Animal study: Revoltella RP, et al. Cell Transplant 2008;17(6):665-678 PMID:18819255
Hypoplastic Left Heart Syndrome
Statistics 0.16-0.36 per 1000 live births from Fyler DC. Pediatrics 1980;65(2Pt2):375-461 (not on-line)
Neonatal Oxygen Deprivation
Statistics Hypoxic Ischemic Encephalopathy (HIE) 2 per 1000 are from
Smith, J. etal. BJOG 2000;107(4):461-6 doi: 10.1111/j.1471-0528.2000.tb13262.x
Liao, Y, Cotten, M, Tan, S, Kurtzberg, J & MS Cairo, MS 2013;
Bone Marrow Transplantation 48:890-900 doi:10.1038/bmt.2012.169
Premature Lungs
Statistics BronchoPulmonary Dysplasia (BPD) 25% babies born wieghing under 1500gm from
Van Marter LJ. Semin Fetal Neonatal Med. 2009;14(6):358-66 doi: 10.1016/j.siny.2009.08.007.
Traumatic Brain Injury
Statistics on occurence from Brain Injury Assoc. of America
Cox Jr., CS et al. Neurosurgery 2011; 68(3):588-600 doi: 10.1227/NEU.0b013e318207734c
Type 1 Diabetes
Statistic 1.7 per 1000 ages birth-19 is prevalence from Centers for Disease Control (CDC)
Haller MJ, et al. Diabetes Care 2011;34(12):2567-9. PMCID: PMC3220832
Yong Zhao, et al. BioMed Central Medicine 2012; 10:3 doi:10.1186/1741-7015-10-3
Science Daily Report on diabetes reversal with the "Stem Cell Educator" containing allogeneic cord blood.