A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs)

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"Assessing new blood cells growth after transplant using cord blood units that do not meet FDA guidelines but meet NMDP guidelines"
Age:
18-100 years old
Gender:
Any
Healthy Volunteers:
No
Keywords:
Bone marrow transplant, Hodgkin lymphoma, leukemia, multiple myeloma, Non-Hodgkin lymphoma
Type:
Drug study
Investigator:
Description
This study is an access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs) in pediatric and adult patients with hematologic malignancies and other indications.
We hope to learn more about how well your new blood cells grow after a transplant using cord blood units that do not meet all the rules set by the Federal Drug Administration (FDA), but do meet the rules set and followed by the National Marrow Donor Program (NMDP).
You are being asked to take part in this study because you are going to have a 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. 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 units(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 blood counts after transplant.
This study requires
Receive the cord blood unit transplant according to standard care procedures. Cord blood unit(s) will be infused into one of your veins.

Allow your medical data to be collected.
Who can participate?
Inclusion Criteria:

- Disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment

- Signed informed consent (and signed assent, if applicable) obtained prior to study enrollment

- Pediatric and adult patients of any age


Exclusion Criteria:

- Patients who are receiving only licensed CBUs

- Cord blood transplant recipients at international transplant centers

- Patients who are enrolled on another IND protocol to access the unlicensed CBU(s)

- Patients whose selected unlicensed CBU(s) will be more than minimally manipulated
Resources
Schedule
Study duration and period
One year
Recruitment period
From Oct. 25, 2011
Location
UC Davis Comprehensive Cancer Center
2279 45th Street
Sacramento, CA 95817
Contact
Caren Galloway
Research Topic
Conditions:
  • Hematologic Malignancies
  • Inherited Disorders of Metabolism
  • Inherited Abnormalities of Platelets
  • Histiocytic Disorders
  • Acute Myelogenous Leukemia (AML or ANLL)
  • Acute Lymphoblastic Leukemia (ALL)
  • Other Acute Leukemia
  • Chronic Myelogenous Leukemia (CML)
  • Myelodysplastic (MDS) / Myeloproliferative (MPN) Diseases
  • Other Leukemia
  • Hodgkin Lymphoma
  • Non-hodgkin Lymphoma
  • Multiple Myeloma/ Plasma Cell Disorder (PCD)
  • Inherited Abnormalities of Erythrocyte Differentiation or Function
  • Disorders of the Immune System
  • Automimmune Diseases
  • Severe Aplastic Anemia

Have any questions or want to learn more? Leave your contact details below and the research team will reach out to you.


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