CHLA Clinical Research Studies
Having volunteers participate in research studies and clinical trials is critical to our research efforts. Thousands of children and families are involved in our patient-centered studies every year. Many of the treatments used today are based on the results of past research studies and clinical trials conducted with our patients. Our scientific and clinical experts take the best ideas from the laboratory -- to the patient -- in the form of promising new treatments.
By searching our study directory, you may identify research that could impact the life of your child or of another child you know. Because the number of available research studies and clinical trials for children nationwide is small, every participant makes a significant contribution.
In addition to enrolling children with certain diseases in order to study treatments and prevention of those diseases, we also need to study healthy children. Ask your child’s doctor about volunteer study options that may be suitable for your child.
Please contact the study staff listed in your search results for more information.
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|Study Details - ID: CHLA-18-00131|
Hypoplastic Left Heart Syndrome
Safety of UCB-MNC Delivered into the Myocardium in HLHS Subjects
|Full Title of Study:|
Phase I safety of autologous umbilical cord blood derived mononuclear cells during surgical Stage II palliation of Hypoplastic Left Heart Syndrome
|Phase/Type of Study:|
|Purpose of Research:|
To determine the safety and feasibility of autologous umbilical cord blood-derived mononuclear cells delivered into the myocardium of the right ventricle during planned Stage II Glen surgical procedure for individuals with hypoplastic left heart syndrome.
1.Child's autologous Umbilical cord blood as the source for mononuclear cells (UCB-MNC)product is determined by the sponsor to be acceptable for release to the investigational site for investigational use. 2. Mother's serology test results are negative for HIV, Hepatitis B, and Hepatitis C. 3. Individuals with HLHS having undergone Stage I surgical palliation and undergoing planned Stage II palliative Glen surgery. 4. Ages up to 18 months are eligible
This is a 2 year study and clinical data will be collected at the time of pre-implant baseline, implant, and planned follow-ups at Day 1, Day 7/Discharge (whatever comes first), 6 weeks, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 36 months, 48 months and 60 months post implant.
Ram Kumar Subramanyan, MD
|Coordinator Contact Name:|