cord blood stem cells diseases treated

Autologous Clinical Trials

Written by Andrew Ripps. Posted in News

Cord blood has been successfully used for more than 20 years to treat many serious diseases. Today, clinical trials are investigating new therapies using a child’s own cord blood stem cells for conditions that currently have no treatment.

Current research using cord blood in regenerative medicine therapies requires a child’s own stem cells and is only available to families who bank cord blood at birth. If your child has his or her own cord blood stored with AssureImmune and you are interested in receiving information about current and emerging clinical trials, contact us.

AssureImmune is grateful to Dr. Avi Treves, the Deputy Director of the Cancer Research Center at the Sheba Medical Center, Israel, who offers scientific advice concerning the clinical trials.

Cord blood stem cells are currently being evaluated as treatment in clinical trials for the following conditions:

   

CP (cerebral palsy)

1. Cerebral palsy - Phase 1 study, results have been published  (Duke University, United States)
A pilot study was conducted by Dr. Joanne Kurtzberg and other investigators to determine the safety and feasibility of intravenous administration of autologous umbilical cord blood in young children with acquired neurological disorders. Most of the cord blood units were electively stored in private Cord Blood banks.
The conclusion of the study was that IV infusion of autologous Cord Blood is safe and feasible in young children with neurological injuries.
For more information click here.

2. Cerebral palsy - Phase 2 study  (Duke University, United States)
Dr. Joanne Kurtzberg at Duke University is conducting an FDA-regulated clinical trial evaluating infusions of a child’s own cord blood stem cells to help treat the effects of cerebral palsy.
This study is currently recruiting participants.
For more information click here»

3. Cerebral palsy - Phase 2 study (Georgia Health Sciences University, United States)
Dr. James Carroll at the Georgia Health Sciences University is conducting the first FDA-regulated clinical trial using cord blood stem cell infusions to treat children with cerebral palsy.
This study is currently recruiting participants.
For more information click here»

 4. Cerebral palsy - Phase 1 study (Monterrey, Mexico)
The purpose of this study is to determine whether the plasticity of autologous intravenous application of cord blood stem cells would improve the clinical course of asphyxiated (severely deficient supply of oxygen to the body) newborns.
This study is currently recruiting participants.
For more information click here»

5. Cerebral palsy – currently waiting for Phase 2 study approval (Australia)
Australian researchers want to assess the impact of cord blood stem cells on the brains of children with cerebral palsy.
For more information click here»
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Traumatic brain injury (TBI) in children

1. Traumatic Brain Injury (TBI) - Phase 1 study (The University of Texas, United States)
TBI is the most common cause of death in young children.
Dr. Charles Cox, professor of pediatric surgery at The University of Texas Health Science Center in Houston (UTHealth), is leading an FDA-regulated trial studying the safety of a child’s own cord blood stem cells in the treatment of traumatic brain injury (TBI).
For more information click here»

2. Neonatal Hypoxic-ischemic Encephalopathy (HIE) - Phase 1 study (Duke University, United States)
This is a pilot study to test feasibility of collection, preparation and infusion of a baby’s own (autologous) umbilical cord blood in the first 14 days after birth if the baby is born with signs of brain injury.
This study is currently recruiting participants.
For more information click here»
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Hearing loss

Hearing Loss (Memorial Hermann Hospital, United States)
A new clinical trial is laying the groundwork to help transform medical care for patients with hearing loss. This innovative study, held at Children’s Memorial Hermann Hospital in Houston, Texas, will evaluate an infusion of a child’s own (autologous) cord blood stem cells to treat acquired hearing loss.
For more information click here»
This study has been suspended after starting recruiting patients (August 2012).
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Diabetes Type 1

1. Juvenile Diabetes (type 1) 
Phase 1 study: results have been published (University of Florida, United States)
Phase 2: the University of Florida is in the midst of a Phase 2 investigation of the use of a child’s own cord blood stem cells to prolong insulin production in those suffering from juvenile (type 1) diabetes. Beginning in 2006, a group of CBR clients and other children who had been diagnosed with the condition were identified and eventually enrolled in the Phase 1 trial. Today, the University of Florida researchers continue their work in a Phase 2 study.

The Phase 1 study that has been conducted used autologous umbilical cord blood (UCB) infusion to ameliorate Type 1 Diabetes patients. Having previously reported on the first 15 patients reaching 1 year of follow-up, another report brings the complete results after two years of follow-up. A total of 24 Type 1 Diabetes patients (median age 5.1 years) received a single intravenous infusion of autologous UCB cells and underwent metabolic and immunologic assessments.

The research conclusions were that autologous UCB infusion in children with Type 1 Diabetes is safe and induces changes in Treg frequency (subpopulation of T cells which modulate the immune system) but fails to preserve C-peptide (Marker of endogenous insulin production, which is used to monitor beta cell activity).
For more information click here»

2. Juvenile Diabetes (type 1) - the recruitment of participants for Phase 2 study has ended (University of Florida, United States).
In this Phase 2 study the investigators are trying to see if a single intravenous infusion of autologous (self) cord blood cells followed by one year of daily vitamin D and omega 3 fatty acid supplementation can preserve beta cell function (prolong “honeymoon”) in children with Type 1 Diabetes.
All subjects will continue to use insulin therapy as needed to maintain the best possible glucose control.

This study is a follow-up to an initial study of cord blood infusion alone in which 23 (24?) children received autologous cord blood. The initial study was 100% safe but additional studies like the one described above are needed to determine how to improve cord blood based therapy.
For more information click here»
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Heart diseases

1. Hypoplastic Left Heart Syndrome – Phase 1 study (Duke University, United States).
Safety and feasibility study of umbilical cord blood cells for infants with Hypoplastic Left Heart Syndrome.
The purpose of the study is to evaluate the feasibility and safety of collecting and infusing autologous umbilical cord blood (UCB) in newborn infants with hypo plastic left heart syndrome (HLHS).
This study is currently recruiting participants.
For more information click here»

2. Complex critical congenital heart diseases – CHDs (Kyiv, Ukraine)
The first clinical experience of complete repair of complex critical congenital heart diseases (CHDs) in the first hours of life using autologous umbilical cord blood (UCB).

Prenatal diagnosis and harvesting of autologous UCB allow to modify preoperative management and to perform corrective surgery in the first hours of a patient’s life. This approach can afford avoiding homologous blood transfusion and preventing development of hypoxemia and heart failure.

The conclusion of the study was that the use of autologous umbilical cord blood is feasible in neonatal open heart surgery. Complete surgical repair of complex critical CHD can be applied successfully to neonates within the first hours of life.
For more information click here»
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Autism

In August 2012, Sutter Neuroscience Institute and CBR, launched the first FDA-approved clinical trial to assess the use of a child’s own cord blood stem cells to treat select patients with autism. 

This first-of-its-kind placebo controlled study will evaluate the ability of an infusion of cord blood stem cells to help improve language and behavior.  The study will enroll 30 children between the ages of two and seven, with a diagnosis of autism. Enrolled participants will receive two infusions—one of the child’s own cord blood stem cells and one of a placebo – over the course of 13 months.
This trial is currently recruiting participants.
For more information click here»
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* Last updated August 2012