Cord Blood and Tissue Research and Trials

Umbilical cord blood therapy for cerebral palsy

Overview:
This randomised, placebo-controlled, double-blind clinical trial used donated (allogeneic) cord blood in conjunction with the hormone erythropoietin in children with cerebral palsy (CP). The study results showed significant improvements in the motor and cognitive function of these children. The improvements with cord blood were more favourable when the donor was a closer match to the patient, suggesting great potential for autologous (child's own) cord blood transfusion in patients with CP.

Location: South Korea
Trial design: Safety and efficacy
Status: Completed
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Autologous umbilical cord blood reinfusion in children with cerebral palsy

Overview:
In a larger clinical trial at Duke University researchers are evaluating the effectiveness of autologous (child's own) cord blood infusion in the treatment of children with CP. This randomised, controlled trial aims to recruit 120 children with CP over a 2 year period. Participants will be given their own cord blood or a placebo to determine the effects on their neurodevelopmental function and quality of life. The study is estimated to be completed in January 2016.

Location: North Carolina, USA
Trial design: Efficacy study
Status: Active - not recruiting
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Safety and effectiveness of cord blood in cerebral palsy in children

Overview:
This clinical trial is assessing the safety and effectiveness of an infusion of autologous (child's own) cord blood in children who have motor disability due to cerebral palsy. The researchers are currently recruiting (up to 40) children between the ages of 1 and 12 years with cerebral palsy with an estimated completion date in July 2015.

Location: Georgia, USA
Trial design: Safety and efficacy
Status: Open - currently recruiting
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Cord reinfusion in type 1 diabetes (CoRD) pilot study

Overview:
Australian researchers at The Children's Hospital at Westmead, in a world first clinical trial (CoRD Study), are investigating the potential to prevent or delay the onset of type 1 diabetes (T1D) in high risk children using a child's own (autologous) cord blood. This pilot study funded by Cell Care and is open to parents across Australia who have stored (or planning to store) their child's own (autologous) cord blood. The trial aims to recruit 400-600 participants in the initial screening phase to identify children at high risk of developing T1D. A total of 20 children identified at high risk will be offered reinfusion of their cord blood. Participants will be monitored and followed for up to 3 years.

Location: Sydney, Australia
Trial design: Pilot study
Status: Closed

Cord blood infusion for type 1 diabetes mellitus (T1DM)

Overview:
Researchers in Bavaria, Germany, aim to recruit 23 children from the age of 1 with T1D mellitus to undergo infusion of autologous (their own) cord blood in an attempt to regenerate the insulin producing cells in the pancreas and improve blood glucose control. As secondary goals, the investigators aim to track the migration of transfused cord blood stem cells and study the potential changes in metabolism and immune function leading to islet regeneration.

Location: Bavaria, Germany
Trial design: Safety and efficacy
Status: Active – not recruiting
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Autologous cord blood stem cells for autism

Overview:
The purpose of this trial is to determine the effect of umbilical cord blood infusion in treating children with autism. The trial is being undertaken by the Sutter Institute for Medical Research in Sacramento California and expects to recruit 30 children from 2 to 7 years of age that have been diagnosed with autism. Participants will be randomly divided into two groups. One group will receive an infusion of their own umbilical cord blood (initial experimental group). The other group will receive a placebo infusion of saline, but then after 24 weeks, they will receive their own umbilical cord blood. The initial experimental group will receive a placebo injection at 24 weeks. Both groups will be tested at 24 weeks after initial infusion, and then again after another 24 weeks. The participants, their carers and their doctors will not know which group they have been assigned to. In the follow-up period each child will be monitored for complications and changes in their clinical condition.

Location: California, USA
Trial design: Efficacy study
Status: Completed
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Autologous umbilical cord blood infusion for children with autism spectrum disorder

Overview:
This study is being undertaken at the Duke University Medical Centre. The study is a prospective phase 1 single-centre trial designed to determine the safety of a single intravenous infusion of autologous umbilical cord blood in children with Autism Spectrum Disorder (ASD). The trial aims to recruit 20 children between 24 and 72 months of age with a diagnosis of ASD with stored autologous (their own) cord blood. Participants in the study will receive an infusion of their own cord blood, with follow up assessments at 6 and 12 months after the infusion.

Location: North Carolina, USA
Trial design: Safety and efficacy
Status: Active – not yet recruiting
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Autologous stem cell infusion for children with acquired hearing loss

Overview:
The trial is being undertaken at the Florida Hospital in Orlando, Florida. The purpose of this study is to determine if autologous (child's own) umbilical cord blood infusion in children with acquired hearing loss is safe, feasible, improves inner ear function, audition and language development. Researchers aim to enrol 10 children between 6 weeks to 6 years of age. All participants will receive a single infusion of their own cord blood. The estimated completion date for this study is January 2016.

Location: Florida, USA
Trial design: Safety study
Status: Open – recruiting

Study of purified umbilical cord blood CD34+ stem cell on chronic ischaemic stroke

Overview:
This study is being conducted by researchers at the China Medical University Hospital in Taiwan. The purpose of the study is to determine the safety and effectiveness of brain transplants of CD34+ stem cells obtained from umbilical cord blood. The aim is to recruit participants between 35 years to 70 years of age who have had an ischaemic stroke more than 6 months and less than 60 months ago. Participants will receive umbilical cord blood stem cells injected into the brain around the site damaged by stroke, in combination with antiplatelet medication and rehabilitation. The donor (allogeneic) cord blood units will be obtained from cord blood banks in USA and Taiwan and will be closely HLA ‘matched' to the recipient. The study start date was January 2013.

Location: Taichung, Taiwan
Trial design: Safety and efficacy
Status: Not yet recruiting
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