DONOR: Donors must meet all criteria for donation as per 21 Code of Federal Regulations (CFR)1271 Subpart C
DONOR: Donors who do not meet 21 CFR 1271 Subpart C requirements per the Food and Drug Administration (FDA) to donate
DONOR: Regarding donation eligibility, is identified as either:\r\n* Completed the process of donor eligibility determination as outlined in 21 Code of Federal Regulations (CFR) 1271 and agency guidance; OR\r\n* Does not meet 21 CFR 1271 eligibility requirements, but has a declaration of urgent medical need completed by the principal investigator or physician sub-investigator per 21 CFR 1271
DONOR: Identified as either:\r\n* Completed the process of donor eligibility determination as outlined in 21 Code of Federal Regulations (CFR) 1271 and agency guidance; OR\r\n* Does not meet 21 CFR 1271 eligibility requirements, but has a declaration of urgent medical need completed by the principal investigator or physician sub-investigator per 21 CFR 1271
The donor-recipient Human Leukocyte Antigen (HLA) match criteria required for participation in this protocol are not research subjects in this study and they must meet criteria as National Marrow Donor Program (NMDP) donors. Procedures for selection of donors and stem cell dose will follow FDA Code of Federal Regulations requirements for Blood Products (21 CFR 640) and Human Cellular and Tissue Based Products (21 CFR 1271). The standard institutional practices for stem cell transplants also will be followed. The donors are:
DONOR: Donor selection will be in compliance with 21 Code of Federal Regulations (CFR) 1271
DONOR: Donors who fail eligibility requirements for donation of cells or tissue per section 21 Code of Federal Regulations (CFR) 1271 for donation of a HCT/product (P) will be excluded unless use of the cells complies with 21 CFR 1271.65(b)(iii) (urgent medical need) or with 21 CFR 1271.65(b)(i) (allogeneic use in a first-degree or second-degree relative)
MSC DONOR: donor must meet the selection and eligibility criteria as defined by the Foundation for the Accreditation of Hematopoietic Cell Therapy (FACT) and Food and Drug Administration (FDA) 21 Code of Federal Regulations (CFR) Part 1271
INCLUSION CRITERIA - HPC-A CELL DONOR: Meets donation eligibility requirements as outlined by 21 Code of Federal Regulations (CFR) 1271
DONOR: meets donation eligibility requirements as outlined by 21 Code of Federal Regulations (CFR) 1271 and agency guidance
DONOR: Regarding donation eligibility, is identified as either:\r\n* Completed the process of donor eligibility determination as outlined in 21 case report form (CFR) 1271 and agency guidance; OR\r\n* Does not meet 21 CFR 1271 eligibility requirements, but has a declaration of urgent medical need completed by the principal investigator or physician sub-investigator per 21 CFR 1271
Has a partially HLA-matched single UCB unit (>= 4 of 6) with adequate cell dose; UCB units must fulfill eligibility as outlined in 21 Code of Federal Regulations (CFR) 1271 and agency guidance
Regarding eligibility, is identified as either:\r\n* Completed the process of donor eligibility determination as outlined in 21 CFR 1271 and agency guidance; OR\r\n* Does not meet 21 CFR 1271 eligibility requirements, but has a declaration of urgent medical need completed by the principal investigator or physician sub-investigator per 21 CFR 127
DONOR: Has completed the process of donor eligibility determination as outlined in 21 Code of Federal Regulations (CFR) 1271 and agency guidance; OR
DONOR: Does not meet 21 CFR 1271 eligibility requirements, but has a declaration of urgent medical need completed by the principal investigator or physician sub-investigator per 21 CFR 1271
DONOR: Donor selection will be in compliance with 21 Code of Federal Regulations (CFR) 1271
Individuals with normal skin and Fitzpatrick skin type II, III or IV (21 Code of Federal Regulations [CFR] 352.72)
Participants/volunteers from the vulnerable population, as defined by 45 Code of Federal Regulations (CFR) 46