CD34+ Cell Enriched and T Cell Depleted Allogeneic Stem Cell Transplantation for Patients With Mismatched Related Donors or Borderline Organ Function
Status: | Recruiting |
---|---|
Conditions: | Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | Any - 35 |
Updated: | 4/2/2016 |
Start Date: | May 2014 |
End Date: | December 2020 |
An Expanded Access Study Using the CliniMACS System to Offer Therapeutic Manipulated Grafts That Are CD34 Cell Enriched and T Cell Depleted for Allogeneic Stem Cell Recipients With Mismatched Related Donors or Borderline Organ Function
The purpose of this protocol is to provide access to the CliniMACS® System to hematopoietic
cell transplant (HSCT) patients who do not have a matched related donor. The CliniMACS
system is currently approved for use in patients who have AML, and a genetically matched
sibling donor. Through this protocol, the investigators will be able to offer potentially
life-saving transplants to patients who have genetically mis-matched donor, who have no
other options for treatment.
cell transplant (HSCT) patients who do not have a matched related donor. The CliniMACS
system is currently approved for use in patients who have AML, and a genetically matched
sibling donor. Through this protocol, the investigators will be able to offer potentially
life-saving transplants to patients who have genetically mis-matched donor, who have no
other options for treatment.
Inclusion Criteria:
- Participant age is 0 (newborn) to 35 years-old.
- Participant has a disorder affecting the hematopoietic system that are inherited,
acquired, or a result from the myeloablative treatment that can benefit from
alternative stem cell transplantation according to standard practice guidelines for
including patients for transplant.
- Participant's medical screening clears s/he for allogeneic transplantation as per
current institutional SOP based on standards of foundation for accreditation of
cellular therapy and stem cell transplantation (FACT);
- Participant must lack a healthy, HLA-identical related or unrelated donor unless s/he
has a borderline organ function that will preclude the recipient from receiving a
curative therapy due to the need of post-HSCT immunosuppressive therapy.
- Participant must have a matched or mismatched-related donor who is:
- Able to receive granulocyte colony-stimulating factor (G-CSF) and undergo apheresis
either through placement of catheters in antecubital veins or a temporary central
venous catheter OR agrees on a bone marrow harvest;
- Healthy as per donor selection screening (following current SOP based on standards of
foundation for accreditation of cellular therapy and stem cell transplantation -
FACT);
- Willing to participate and sign consent.
- Participant or Legal Authorized Representative is able to sign informed consent (and
signed assent, if applicable) for transplant.
Exclusion Criteria:
- Participant does not qualify for an allogeneic transplant due to medical screening,
underlying disease, or lack of alternative donors.
- Any condition that compromises compliance with the procedures of this protocol, as
judged by the principal investigator.
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