Inability to comply with protocol-required procedures
Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required procedures.
Subjects likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the subject and investigator's knowledge
Central nervous system (CNS) diseases and major psychiatric diseases or inability to comply to the protocol procedures
Inability to comply with protocol required procedures
Subject likely to not be available to complete all protocol required study visits or procedures to the best of the subject and investigator's knowledge
Inability to comply with protocol or study procedures
Inability to comply with protocol required procedures
Inability to comply with protocol or study procedures
223 Subjects likely to not be available to complete all protocol- required study visits or procedures including BM aspirates/biopsies, and/or to comply with all required study procedures to the best of the subject and investigator's knowledge.
Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the subject's and investigator's knowledge.
Inability to comply with protocol required procedures.
Inability to comply with protocol or study procedures
Inability to comply with protocol required procedures
Patient must be able to tolerate the procedures required in this study including periodic blood sampling, study related assessments, and management at the treating institution for the duration of the study. Inability to comply with protocol or study procedures (for example, an inability to swallow tablets) will be an exclusion criterion.
Inability to comply with protocol or study procedures
201 Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the subject and investigator's knowledge.
Stated willingness to comply with all required (non-optional) study procedures and be available for the duration of the study
Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the subject and investigator's knowledge.
Unwillingness or inability to comply with procedures required in this protocol
Unwillingness or inability to comply with study procedures
Unwillingness to follow study protocol and compliance procedures
Unwillingness or inability to comply with study and follow-up procedures
Unwillingness or inability to follow the procedures required in the protocol.
Inability or unwillingness to comply with study and/or follow-up procedures outlined in the protocol.
Unwillingness or inability to follow the procedures required in the protocol.
Unwillingness or inability to follow the procedures required in the protocol
Unwillingness or inability to comply with procedures required in this protocol
Unwillingness or inability to comply with procedures required in this protocol
Unwillingness or inability to comply with study and follow-up procedures
Unwillingness or inability to comply with study and follow-up procedures
Inability or unwillingness to comply with study procedures and protocol
No unwillingness or inability to follow protocol requirements
Unwillingness or inability to follow the procedures required in the protocol
Inability or unwillingness to comply with, or follow study procedures
Unwillingness or inability to follow the procedures outlined in the protocol
Inability or unwillingness to comply with study and/or follow-up requirements
Unwillingness or inability to comply with procedures required in this protocol.
Unwillingness or inability to follow the procedures required in the protocol
Unwillingness or inability to comply with study and follow-up procedures
Inability or unwillingness to comply with study and/or follow-up procedures outlined in the protocol
Inability or unwillingness to comply with the treatment protocol, follow-up, or research tests
Unwillingness or inability to comply with study and follow-up procedures
Unwillingness or inability to follow the procedures outlined in the protocol.
Unwillingness or inability to comply with procedures required in this protocol.
Unwillingness or inability to follow the procedures outlined in the protocol
Unwillingness or inability to comply with procedures required in this protocol
Unwillingness or inability to follow the procedures required in the protocol.
Inability or unwillingness to understand or cooperate with study procedures
Inability or unwillingness to follow study protocol.
Inability or unwillingness to comply with skin care instructions and follow-up
Inability or unwillingness to cooperate with the study procedures
Unwillingness or inability to comply with study procedures
Inability to comprehend or unwillingness to follow instructions for the study procedures required per protocol
Inability or unwillingness to comply with study and/or follow-up procedures outlined in the protocol. Note the following pertains to patients enrolled in France
Unwillingness to participate or inability to comply with the protocol for the duration of the study
Unwillingness or inability to comply with the study protocol for any other reason
Unwillingness or inability to comply with the study protocol for any other reason
Unwillingness or inability to comply with the study protocol for any reason
Inability or unwillingness to comply with radiation safety procedures or protocol requirements
Inability or unwillingness to comply with radiation safety procedures or protocol requirements
Unwillingness to participate or inability to comply with the protocol for the duration of the study
Subject has an inability or unwillingness, in the opinion of the investigator, to comply with the protocol requirements
Unwillingness to give written informed consent, unwillingness to participate, or inability to comply with the protocol for the duration of the study
Unwillingness or inability to comply with protocol.
Unwillingness or inability to comply with the protocol
Unwillingness to participate or inability to comply with the protocol for the duration of the study
Unwillingness or inability to provide written informed consent and comply with the study protocol for any reason
Inability or unwillingness to comply with birth control requirements or regional REMS/RevAid programs
Unwillingness to give written informed consent, unwillingness to participate, or inability to comply with the protocol for the duration of the study
Unwillingness or inability to comply with the protocol
Unwillingness to participate or inability to comply with the protocol for the duration of the study
Unwillingness or inability to comply with protocol.
Unwillingness to participate or inability to comply with the protocol for the duration of the study
Is unwilling to give written informed consent, unwillingness to participate, or inability to comply with the protocol for the duration of the study
Unwillingness or inability to comply with the protocol
Unwillingness or inability to comply with the study protocol for any reason.
Unwillingness to participate or inability to comply with the protocol for the duration of the study
Unwillingness or inability to comply with mandated blood draws.
Unwillingness to comply with the requirements of the protocol
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