Palo Alto, California 94305

  • malignant Diseases

Purpose:

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.


Criteria:

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.


NCT ID:

NCT02162511


Primary Contact:

Principal Investigator
Rajni Agarwal, MD
Stanford University


Backup Contact:

N/A


Location Contact:

Palo Alto, California 94305
United States

Rajni Agarwal, MD
Phone: 650-725-9250

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: September 27, 2021

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