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Research and Trials

There is an expanding range of research and clinical trials evaluating how cord blood and tissue stem cells may contribute to new therapies for a broad number of conditions.

Cord blood research and trials

New fields of regenerative medicine are investigating cord blood as a potential source of reparative stem cells for conditions including; cerebral palsy, type 1 diabetes, autism, hearing loss and stroke27

Current clinical trials using cord blood

Condition

Number of trials

Type 1 diabetes 2
Cerebral palsy 3
Alzheimer's disease 1
Autism 1
Burns 1
Hearing loss 1
Metabolic disorders 4
Solid tumours 2
Stroke 1
Spinal cord injury 2

Cerebral palsy cord blood trials

Cerebral palsy cord blood 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 
Find out more here

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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Type 1 diabetes cord blood trials

Type 1 diabetes cord blood trials

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: Open - currently recruiting 
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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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Autism cord blood trials

Autism cord blood trials

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: Open – recruiting
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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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Hearing loss cord blood trials

Hearing loss cord blood trials

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 
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Stroke cord blood trials

Stroke cord blood trials

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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Cord tissue research and trials 

Umbilical cord tissue is stored now with the intention that it may be used in the future for regenerative medicine therapies. Cord tissue is a rich source of mesenchymal stem cells that can regenerate cartilage, bone and other cell types. 

Although research using MSC’s is still at an early stage, the unique properties of these cells make them promising for future cellular therapies. There are numerous clinical studies looking at the role of MSC’s in a wide variety of conditions including: spinal cord injury, brain injury, heart disease, multiple sclerosis and rheumatoid arthritis.

Research and trials using cells from cord tissue:

Pre-clinical research

Clinical trials

Parkinson's disease Rheumatoid arthritis
Rheumatoid arthritis Multiple sclerosis
Stroke Osteoarthritis
Type 1 diabetes Liver transplantation
Liver fibrosis Burns
Lung cancer Lupus
Cartilage Cerebral palsy

Spinal cord injury cord tissue trial

Spinal cord injury cord tissue trial

Efficacy difference between rehabilitation therapy and umbilical cord derived mesenchymal stem cells transplantation in patients with acute or chronic spinal cord injury 

Overview: 
This study is being conducted by researchers at the General Hospital of Chinese Armed Police Forces. 40 patients with traumatic spinal cord injury (20 cases in the acute stage of injury and 20 in the later sequela stage) will receive mesenchymal stem cells (MSC’s) derived from umbilical cord tissue. The study is targeting adult patients with spinal cord injury between the ages of 20 and 50 years.

The MSC’s from human umbilical cord are transplanted directly by injection (lumbar puncture) into the subarachnoid space in the spine. Investigators also plan to follow up 10 patients who receive only rehabilitation and another 10 patients as a control group who accept neither stem cell therapy nor rehabilitation. On this basis, the researchers can compare the efficacy of these two treatments.

Location: Beijing, China
Trial design: Safety and efficacy    
Status: Open
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Brain injury cord tissue trials

Brain injury cord tissue trials

Umbilical cord derived mesenchymal stem cells therapy in hypoxic ischaemic encephalopathy

Overview:
This phase 1 study is being conducted at the First Hospital of Hebei Medical University, where researchers are evaluating the safety and effectiveness of umbilical cord derived mesenchymal stem cells (MSC’s) in the treatment of hypoxic ischaemic encephalopathy brain injury. 

Ten patients are given an intravenous infusion of umbilical cord blood stem cells at the same time. All patients will be evaluated before and after treatment for 15 days, 90 days and 180 days respectively for the curative effect. The study commenced in 2013 and the estimated completion date is December 2014.

Location: Hebei, China
Trial design: Safety and efficacy
Status: Recruiting 
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Heart disease cord tissue trials

Heart disease cord tissue trials

Randomised clinical trial of intravenous infusion of umbilical cord mesenchymal stem cells on cardiopathy (RIMECARD)

Overview: 
This trial aims to evaluate the use of stem cells from umbilical cord in the treatment of heart failure. The trial is being conducted at the Universidad de los Andes in Santiago. 30 participants will have their cardiac function carefully calibrated and recorded three months prior to the commencement of the trial, and be randomly assigned into one of two groups. The experimental group will receive a single intravenous (IV) injection of mesenchymal stem cells that have been obtained from donated cord blood. The control group will receive a placebo intravenous injection. Participants will be monitored for complications and changes in clinical conditions at three monthly intervals for one year. 

Location: Santiago, Chile
Trial design: Safety and efficacy            
Status: Recruiting 
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Multiple sclerosis cord tissue trials

Multiple sclerosis cord tissue trials

Feasibility study of human umbilical cord tissue-derived mesenchymal stem cells in patients with multiple sclerosis

Overview: 
The purpose of this phase 1 study being conducted by the Stem Cell Institute in Panama is to assess the safety and effectiveness of donor (allogeneic) umbilical cord mesenchymal stem cells (MSC’s) administered to patients with multiple sclerosis (MS). The study commenced in January 2014 and aims to recruit 20 patients between the age of 18 and 55 years with MS. Participants will receive an intravenous injection of MSC’s once a day for 7 days and will be followed up after treatment to determine the therapeutic effect  at 4, 12 and 52 weeks. Participants will be evaluated post treatment by neurological assessments: walking time, quality of life survey, and MRI scans of the brain and cervical (neck region) spinal cord. The estimated completion date is August 2017.

Location: Panama City, Panama
Trial design: Safety and efficacy
Status: Recruiting
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Rheumatoid arthritis cord tissue trials

Rheumatoid arthritis cord tissue trials

Safety and efficacy study of umbilical cord-derived mesenchymal stem cells for rheumatoid arthritis

Overview: 
This phase 1/2 study commenced in April 2013 and is being conducted at The 323 Hospital of Chinese People’s Liberation Army. The purpose of this study is to explore the safety and effectiveness of human umbilical cord–derived mesenchymal stem cell (UC-MSCs) transplantation in the treatment of rheumatoid arthritis (RA). 

Researchers are investigating whether the anti-inflammatory effects of UC-MSCs will alleviate the progression of RA in adult patients. Investigators aim to recruit 200 adult participants with RA between the ages of 18 and 70 years to undergo intravenous infusions of UC-MSCs every 3 months for a total of 2 months (4 infusions in total). A comparison group will receive conventional RA drugs and a final comparator group will receive both UC-MSCs and conventional RA drugs.

Location: Shaanxi, China
Trial design Safety and efficacy
Status: Recruiting 
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