A multicenter access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs) for transplantation in pediatric and adult patients with hematologic malignancies and other indications
ID Number 11-1355Principal Investigator(s)
Luis M. Isola
Department(s) or Division(s)
Hematology and Medical Oncology
Since 1989, cord blood banks have been established in six continents and over one million cord blood collections have been performed. Approximately 10,000 cord blood transplants have been performed in children and adults, for malignant and non-malignant conditions.
Most of the cord blood units that are currently available in cord blood banks in the United States and other countries were collected before the FDA set these new standards. Although these cord blood units may not meet FDA standards, they do meet similar standards set and followed by the NMDP for years.
You may qualify to take part in this study because you are going to have a standard of care cord blood transplant and one or more of the cord blood units that are considered by your doctor to be the best choice for your transplant may not meet all the new FDA standards. This study will allow your doctor to use these cord blood units for your transplant. Cord blood units used for transplant on this study must meet standards set by the NMDP (National Marrow Donor Program). If a cord blood unit meets NMDP standards this means that the cord blood unit is suitable for use. This does not however guarantee that the cord blood unit(s) will be successful in treating your disease.
These standards include:
- Making sure the hospital where the cord blood units are collected follows safe procedures to prevent the cord blood units from coming into contact with germs.
- Making sure the cord blood units are stored and labeled in a certain way.
- Making sure the cord blood units are tested for certain viruses and bacteria that could cause illness in the recipient.
The primary purposes of this study are to:
- Provide access to cord blood units for recipients whose best choice for a cord blood unit(s) do not meet all FDA standards, but do meet standards set by the NMDP on this study.
- Assess how well and how quickly blood counts return to normal after transplant in recipients on this study.
Recruiting Patients: Yes