Cryopreserved MMUD BM With PTCy for Hematologic Malignancies
Primary Purpose
Acute Leukemia, Myelodysplastic Syndromes, T-lymphoblastic Lymphoma
Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Cyclophosphamide
Fludarabine
Total Body Irradiation
Busulfan
Mesna
Sirolimus
Mycophenolate Mofetil
Filgrastim
Cyclophosphamide
Bone Marrow Transplant
Sponsored by
About this trial
This is an interventional treatment trial for Acute Leukemia focused on measuring Leukemia, MDS, T-LBL, ALL, AML, ABL, AUL, Bone marrow transplant
Eligibility Criteria
Inclusion Criteria:
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged ≥ 18 and < 71 years (Note: HIV-negative subjects with MDS must be aged <50 at the time of signing the informed consent form)
- Diagnosed with
- Acute leukemias or T-lymphoblastic lymphoma (T-LBL) in 1st or subsequent CR
- Acute lymphocytic leukemia (ALL) or T-LBL as defined by the following:
- < 5% blasts in the bone marrow
- Normal maturation of all cellular components in the bone marrow
- No currently active extramedullary disease (EMD) (e.g., central nervous system (CNS), soft tissue disease)
- ANC ≥ 1,000/mm3
- Acute myeloid leukemia (AML) defined by the following:
- < 5% blasts in the bone marrow
- No blasts with Auer rods
- Normal maturation of all cellular components in the bone marrow
- No currently active EMD (e.g., CNS, soft tissue disease)
- ANC ≥ 1,000/mm3
- Acute biphenotypic leukemia (ABL)/Acute undifferentiated leukemia (AUL) defined by the following:
- < 5% blasts in the bone marrow
- Normal maturation of all cellular components in the bone marrow
- No currently active EMD (e.g., CNS, soft tissue disease)
- ANC ≥ 1,000/mm3
- Myleodysplastic Syndromes (MDS), fulfilling the following criteria:
- Subjects with de novo MDS who have or have previously had Intermediate-2 or High-risk disease as determined by the IPSS. Current Intermediate-2 or High- risk disease is not a requirement
- Subjects must have < 20% bone marrow blasts, assessed within 60 days of informed consent
- Subjects may have received prior therapy for the treatment of MDS prior to enrollment
- Performance status: Karnofsky ≥ 60%
- Adequate organ function defined as:
- Cardiac: LVEF at rest ≥ 35% (RIC cohort) or LVEF at rest ≥ 40% (FIC cohort), or LVFS ≥ 25%
- Pulmonary: DLCO, FEV1, FVC ≥ 50% predicted by pulmonary function tests (PFTs). DLCO value may be corrected or uncorrected for hemoglobin
- Hepatic: total bilirubin ≤ 2.5 mg/dL, and ALT, AST, and ALP < 5 x ULN (unless ALT, AST, and/or ALP are disease related)
- Renal: SCr within normal range for age (see table 5.1B). If SCr is outside normal range for age, CrCl > 40 mL/min/1.73m2 must be obtained (measured by 24-hour (hr) urine specimen or nuclear glomerular filtration rate (GFR), or calculated GFR (by Cockcroft-Gault formula)
- Subjects must have the ability to give informed consent according to applicable regulatory and local institutional requirements
- Availability of deceased HLA MMUD cryopreserved product through Ossium cryobank
- HLA MMUD defined as 4-7/8 HLA-allele matching at MHC class (A, B, or C) or MHC class II (DRB1)
- Additional MHC class II HLA (DP and DQ) typing will be collected, but not incorporated in donor selection
Exclusion Criteria:
- Pediatric patients (17 years or younger)
- Suitable HLA-matched related or 8/8 allele matched (HLA-A, -B, -C, -DRB1) unrelated donor excluding Ossium product
- Autologous HCT < 3 months prior to the time of signing the informed consent form
- Pregnancy or lactation
- Treatment with an investigational drug or other interventional GVHD clinical trials
- Current uncontrolled bacterial, viral or fungal infection (currently taking medication with evidence of progression of clinical symptoms or radiologic findings)
- Prior allogeneic HCT
- Primary myelofibrosis or myelofibrosis secondary to essential thrombocythemia or polycythemia vera
- Subjects with MDS may not receive RIC and must be < 50 years of age at the time of signing the informed consent form
- Any condition(s) or diagnosis, both physical or psychological, or physical exam finding that in the investigator's opinion precludes participation
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
Regmin A (RIC)
Regimen B (FIC)
Regimen C (FIC)
Arm Description
Pre-transplant conditioning treatment with Fludarabine, Cyclophosphamide, and Total Body Irradiation (TBI)
Pre-transplant conditioning treatment with Busulfan and Cyclophosphamide OR Fludarabine
Pre-transplant conditioning treatment with Cyclophosphamide and Total Body Irradiation (TBI)
Outcomes
Primary Outcome Measures
Neutrophil engraftment
Run-in safety phase primary endpoint; Neutrophil engraftment is defined as neutrophil recovery by Day 35. Neutrophil recovery is defined as donor-derived absolute neutrophil count (ANC) ≥ 500/mm3 for three consecutive days with evidence of donor chimerism in bone marrow or peripheral blood. Full donor chimerism is >95%, and mixed donor chimerism is defined as 5-95%.
Cumulative incidence and kinetics of neutrophil and platelet recovery
Main phase primary endpoint; Neutrophil recovery is defined as achieving an absolute neutrophil count (ANC) greater than or equal to 500/mm3 for three consecutive measurements on three different days. The first of the three days will be designated the day of neutrophil recovery. The competing event is death without neutrophil recovery. For subjects who never drop ANC below 500/mm3, the date of neutrophil recovery will be Day 1 post-transplant. Platelet recovery is defined by two different metrics: the first day of a sustained platelet count greater than or equal to 20,000/mm3 or greater than or equal to 50,000/mm3 with no platelet transfusions in the preceding seven days. The first day of sustained platelet count above these thresholds will be designated the day of platelet engraftment. For subjects who never drop their platelet count below 20,000/mm3, the date of platelet recovery will be Day 1 post HCT.
Overall survival (OS)
Main phase primary endpoint; The primary endpoint for the study is OS at 1-year post-HCT. The event is death from any cause. The time to this event is the time from HCT to death, loss to follow-up, or end of study (whichever comes first). Subjects who are lost to follow-up prior to 1-year will be censored at the time of the last observation, and the OS probability will be estimated using the Kaplan-Meier method.
Secondary Outcome Measures
Cumulative incidences of aGVHD and cGVHD
aGVHD is defined as any skin, gastrointestinal or liver abnormalities fulfilling the criteria of grades II-IV or grades III-IV. cGVHD is defined per National Institutes of Health (NIH) Consensus Criteria and includes organ involvement and severity, and overall global composite score (mild/moderate/severe).
Transplant-related mortality (TRM)
TRM is defined as death without evidence of disease progression or recurrence. TRM will be evaluated at Day 100, 180, and 1-year (Day 365).
NK, B- and T-cell immune reconstitution
Quantitative assessments of peripheral blood CD3, CD4, CD8, CD19 positive lymphocytes will be done through flow cytometric analysis at Days 35, 100, 180, and 365 post-HCT. Qualitative assessments will be tabulated according to time from transplant.
Progression free survival (PFS)
Progression free survival will be estimated at 1-year (Day 365) post-transplant. An event for this time to event outcome is defined as disease relapse or progression, or death by any cause.
Event free survival (EFS)
EFS will be estimated at 12 months post-HCT. An event for this time to event outcome includes graft failure (PGF by Day 35 or secondary graft failure), relapse or progression of underlying disease, death, grade III-IV acute GVHD, or NIH-severe chronic GVHD.
GVHD relapse free survival (GRFS)
GRFS will be estimated at 1-year (Day 365) post-transplant. An event for this time to event outcome is defined as relapse or progression of underling disease, graft failure, grade III-IV acute GVHD, chronic GVHD requiring systemic immune suppression, or death by any cause.
Cumulative incidence of cytokine release syndrome (CRS)
Overall incidence of CRS of any grade and grade 3 or 4 CRS post-transplant will be reported on all patients. CRS will be defined and graded using the American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading criteria.
Donor chimerism
Peripheral blood chimerism (% of donor chimerism) in whole blood (unsorted) will be described on Day 35, 56, 100, 180, and 1-year (Day 365). Donor cell engraftment will be assessed with donor/recipient chimerism studies at Day 100. Chimerism may be assessed in CD3 blood cell fraction. For the purpose of this protocol, mixed chimerism is defined as the presence of donor cells, as a proportion of total cells to be less than 95% but at least 5% in the bone marrow or peripheral blood. Full donor chimerism is defined as greater than or equal to 95% of donor cells. Mixed and full chimerism will be evidence of donor cell engraftment. Donor cells of less than 5% by Day 35 will be considered as graft rejection. The proportion of patients with each level of chimerism described above will be described as part of this outcome. For sorted blood cell fractions, CD3+ donor cell chimerism will be used to define the donor/recipient chimerism status.
Cumulative incidences of viral reactivations and infections
The incidence of Cytomegalovirus (CMV), Epstein-Barr virus (EBV), BK virus, Adenovirus (ADV), and Human herpesvirus (HHV-6) viral activations and infections at Days 100, 180 and 1-year (Day 365).
Cumulative incidence of primary disease relapse/progression
Testing for recurrent malignancy in the blood, bone marrow or other sites will be used to assess relapse and progression post-HCT. For the purpose of this study, relapse is defined by either morphological, cytogenetic/molecular or radiological evidence of disease consistent with pre-HCT features, in line with institutional standards. The event for this endpoint is the time interval from HCT to relapse/recurrence of disease or to last follow-up through 1-year (Day 365) post-HCT. Death in remission is considered a competing risk.
Full Information
NCT ID
NCT05170828
First Posted
November 12, 2021
Last Updated
December 8, 2021
Sponsor
Ossium Health, Inc.
Collaborators
Center for International Blood and Marrow Transplant Research
1. Study Identification
Unique Protocol Identification Number
NCT05170828
Brief Title
Cryopreserved MMUD BM With PTCy for Hematologic Malignancies
Official Title
PRESERVE: A Multi-Center Trial Using Banked, Cryopreserved HLA-Mismatched Unrelated Donor Bone Marrow and Post-Transplantation Cyclophosphamide in Allogeneic Transplantation for Patients With Hematologic Malignancies
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 2022 (Anticipated)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
November 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ossium Health, Inc.
Collaborators
Center for International Blood and Marrow Transplant Research
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Multicenter single arm study to assess the safety and efficacy of allogeneic transplantation using cryopreserved bone marrow from deceased MMUD and PTCy, sirolimus and MMF for GVHD prophylaxis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Leukemia, Myelodysplastic Syndromes, T-lymphoblastic Lymphoma, Acute Lymphocytic Leukemia, Acute Myeloid Leukemia, Acute Biphenotypic Leukemia, Acute Undifferentiated Leukemia
Keywords
Leukemia, MDS, T-LBL, ALL, AML, ABL, AUL, Bone marrow transplant
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Regmin A (RIC)
Arm Type
Other
Arm Description
Pre-transplant conditioning treatment with Fludarabine, Cyclophosphamide, and Total Body Irradiation (TBI)
Arm Title
Regimen B (FIC)
Arm Type
Other
Arm Description
Pre-transplant conditioning treatment with Busulfan and Cyclophosphamide OR Fludarabine
Arm Title
Regimen C (FIC)
Arm Type
Other
Arm Description
Pre-transplant conditioning treatment with Cyclophosphamide and Total Body Irradiation (TBI)
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Other Intervention Name(s)
Cytoxan
Intervention Description
pre-transplant conditioning treatment
Intervention Type
Drug
Intervention Name(s)
Fludarabine
Other Intervention Name(s)
Fludara
Intervention Description
pre-transplant conditioning treatment
Intervention Type
Radiation
Intervention Name(s)
Total Body Irradiation
Other Intervention Name(s)
TBI
Intervention Description
pre-transplant conditioning treatment
Intervention Type
Drug
Intervention Name(s)
Busulfan
Other Intervention Name(s)
Busulfelx
Intervention Description
pre-transplant conditioning treatment
Intervention Type
Drug
Intervention Name(s)
Mesna
Other Intervention Name(s)
Mesnex
Intervention Description
given with cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
Sirolimus
Intervention Description
post-transplant treatment for GVHD
Intervention Type
Drug
Intervention Name(s)
Mycophenolate Mofetil
Other Intervention Name(s)
MMF
Intervention Description
post-transplant treatment for GVHD
Intervention Type
Drug
Intervention Name(s)
Filgrastim
Other Intervention Name(s)
G-CSF
Intervention Description
post-transplant treatment for GVHD
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Other Intervention Name(s)
Cytoxan
Intervention Description
post-transplant treatment for GVHD
Intervention Type
Procedure
Intervention Name(s)
Bone Marrow Transplant
Other Intervention Name(s)
Hematopoietic Stem Cell Transplant
Intervention Description
Transplant with investigational bone marrow product
Primary Outcome Measure Information:
Title
Neutrophil engraftment
Description
Run-in safety phase primary endpoint; Neutrophil engraftment is defined as neutrophil recovery by Day 35. Neutrophil recovery is defined as donor-derived absolute neutrophil count (ANC) ≥ 500/mm3 for three consecutive days with evidence of donor chimerism in bone marrow or peripheral blood. Full donor chimerism is >95%, and mixed donor chimerism is defined as 5-95%.
Time Frame
Day 35 Post HCT
Title
Cumulative incidence and kinetics of neutrophil and platelet recovery
Description
Main phase primary endpoint; Neutrophil recovery is defined as achieving an absolute neutrophil count (ANC) greater than or equal to 500/mm3 for three consecutive measurements on three different days. The first of the three days will be designated the day of neutrophil recovery. The competing event is death without neutrophil recovery. For subjects who never drop ANC below 500/mm3, the date of neutrophil recovery will be Day 1 post-transplant. Platelet recovery is defined by two different metrics: the first day of a sustained platelet count greater than or equal to 20,000/mm3 or greater than or equal to 50,000/mm3 with no platelet transfusions in the preceding seven days. The first day of sustained platelet count above these thresholds will be designated the day of platelet engraftment. For subjects who never drop their platelet count below 20,000/mm3, the date of platelet recovery will be Day 1 post HCT.
Time Frame
Day 35 Post HCT
Title
Overall survival (OS)
Description
Main phase primary endpoint; The primary endpoint for the study is OS at 1-year post-HCT. The event is death from any cause. The time to this event is the time from HCT to death, loss to follow-up, or end of study (whichever comes first). Subjects who are lost to follow-up prior to 1-year will be censored at the time of the last observation, and the OS probability will be estimated using the Kaplan-Meier method.
Time Frame
1-year Post HCT
Secondary Outcome Measure Information:
Title
Cumulative incidences of aGVHD and cGVHD
Description
aGVHD is defined as any skin, gastrointestinal or liver abnormalities fulfilling the criteria of grades II-IV or grades III-IV. cGVHD is defined per National Institutes of Health (NIH) Consensus Criteria and includes organ involvement and severity, and overall global composite score (mild/moderate/severe).
Time Frame
1-year Post HCT
Title
Transplant-related mortality (TRM)
Description
TRM is defined as death without evidence of disease progression or recurrence. TRM will be evaluated at Day 100, 180, and 1-year (Day 365).
Time Frame
Day 100 and 1-year Post HCT
Title
NK, B- and T-cell immune reconstitution
Description
Quantitative assessments of peripheral blood CD3, CD4, CD8, CD19 positive lymphocytes will be done through flow cytometric analysis at Days 35, 100, 180, and 365 post-HCT. Qualitative assessments will be tabulated according to time from transplant.
Time Frame
Days 35, 100, 180, and 1-year Post HCT
Title
Progression free survival (PFS)
Description
Progression free survival will be estimated at 1-year (Day 365) post-transplant. An event for this time to event outcome is defined as disease relapse or progression, or death by any cause.
Time Frame
1-year Post HCT
Title
Event free survival (EFS)
Description
EFS will be estimated at 12 months post-HCT. An event for this time to event outcome includes graft failure (PGF by Day 35 or secondary graft failure), relapse or progression of underlying disease, death, grade III-IV acute GVHD, or NIH-severe chronic GVHD.
Time Frame
1-year Post HCT
Title
GVHD relapse free survival (GRFS)
Description
GRFS will be estimated at 1-year (Day 365) post-transplant. An event for this time to event outcome is defined as relapse or progression of underling disease, graft failure, grade III-IV acute GVHD, chronic GVHD requiring systemic immune suppression, or death by any cause.
Time Frame
1-year Post HCT
Title
Cumulative incidence of cytokine release syndrome (CRS)
Description
Overall incidence of CRS of any grade and grade 3 or 4 CRS post-transplant will be reported on all patients. CRS will be defined and graded using the American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading criteria.
Time Frame
Day 14 Post HCT
Title
Donor chimerism
Description
Peripheral blood chimerism (% of donor chimerism) in whole blood (unsorted) will be described on Day 35, 56, 100, 180, and 1-year (Day 365). Donor cell engraftment will be assessed with donor/recipient chimerism studies at Day 100. Chimerism may be assessed in CD3 blood cell fraction. For the purpose of this protocol, mixed chimerism is defined as the presence of donor cells, as a proportion of total cells to be less than 95% but at least 5% in the bone marrow or peripheral blood. Full donor chimerism is defined as greater than or equal to 95% of donor cells. Mixed and full chimerism will be evidence of donor cell engraftment. Donor cells of less than 5% by Day 35 will be considered as graft rejection. The proportion of patients with each level of chimerism described above will be described as part of this outcome. For sorted blood cell fractions, CD3+ donor cell chimerism will be used to define the donor/recipient chimerism status.
Time Frame
Days 35, 56, 100, 180, and 1-year Post HCT
Title
Cumulative incidences of viral reactivations and infections
Description
The incidence of Cytomegalovirus (CMV), Epstein-Barr virus (EBV), BK virus, Adenovirus (ADV), and Human herpesvirus (HHV-6) viral activations and infections at Days 100, 180 and 1-year (Day 365).
Time Frame
Days 100, 180, and 1-year Post HCT
Title
Cumulative incidence of primary disease relapse/progression
Description
Testing for recurrent malignancy in the blood, bone marrow or other sites will be used to assess relapse and progression post-HCT. For the purpose of this study, relapse is defined by either morphological, cytogenetic/molecular or radiological evidence of disease consistent with pre-HCT features, in line with institutional standards. The event for this endpoint is the time interval from HCT to relapse/recurrence of disease or to last follow-up through 1-year (Day 365) post-HCT. Death in remission is considered a competing risk.
Time Frame
1-year Post HCT
Other Pre-specified Outcome Measures:
Title
Length of stay in hospital
Description
Cumulative days alive and out of the hospital in the first 100 days and in the first year post-transplant.
Time Frame
Day 100 Post HCT
Title
Incidence of clinically-significant infections
Description
A clinically significant infection is defined as an infection that requires therapeutic intervention.
Time Frame
1-year Post HCT
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for the duration of the study
Male or female, aged ≥ 18 and < 71 years (Note: HIV-negative subjects with MDS must be aged <50 at the time of signing the informed consent form)
Diagnosed with
Acute leukemias or T-lymphoblastic lymphoma (T-LBL) in 1st or subsequent CR
Acute lymphocytic leukemia (ALL) or T-LBL as defined by the following:
< 5% blasts in the bone marrow
Normal maturation of all cellular components in the bone marrow
No currently active extramedullary disease (EMD) (e.g., central nervous system (CNS), soft tissue disease)
ANC ≥ 1,000/mm3
Acute myeloid leukemia (AML) defined by the following:
< 5% blasts in the bone marrow
No blasts with Auer rods
Normal maturation of all cellular components in the bone marrow
No currently active EMD (e.g., CNS, soft tissue disease)
ANC ≥ 1,000/mm3
Acute biphenotypic leukemia (ABL)/Acute undifferentiated leukemia (AUL) defined by the following:
< 5% blasts in the bone marrow
Normal maturation of all cellular components in the bone marrow
No currently active EMD (e.g., CNS, soft tissue disease)
ANC ≥ 1,000/mm3
Myleodysplastic Syndromes (MDS), fulfilling the following criteria:
Subjects with de novo MDS who have or have previously had Intermediate-2 or High-risk disease as determined by the IPSS. Current Intermediate-2 or High- risk disease is not a requirement
Subjects must have < 20% bone marrow blasts, assessed within 60 days of informed consent
Subjects may have received prior therapy for the treatment of MDS prior to enrollment
Performance status: Karnofsky ≥ 60%
Adequate organ function defined as:
Cardiac: LVEF at rest ≥ 35% (RIC cohort) or LVEF at rest ≥ 40% (FIC cohort), or LVFS ≥ 25%
Pulmonary: DLCO, FEV1, FVC ≥ 50% predicted by pulmonary function tests (PFTs). DLCO value may be corrected or uncorrected for hemoglobin
Hepatic: total bilirubin ≤ 2.5 mg/dL, and ALT, AST, and ALP < 5 x ULN (unless ALT, AST, and/or ALP are disease related)
Renal: SCr within normal range for age (see table 5.1B). If SCr is outside normal range for age, CrCl > 40 mL/min/1.73m2 must be obtained (measured by 24-hour (hr) urine specimen or nuclear glomerular filtration rate (GFR), or calculated GFR (by Cockcroft-Gault formula)
Subjects must have the ability to give informed consent according to applicable regulatory and local institutional requirements
Availability of deceased HLA MMUD cryopreserved product through Ossium cryobank
HLA MMUD defined as 4-7/8 HLA-allele matching at MHC class (A, B, or C) or MHC class II (DRB1)
Additional MHC class II HLA (DP and DQ) typing will be collected, but not incorporated in donor selection
Exclusion Criteria:
Pediatric patients (17 years or younger)
Suitable HLA-matched related or 8/8 allele matched (HLA-A, -B, -C, -DRB1) unrelated donor excluding Ossium product
Autologous HCT < 3 months prior to the time of signing the informed consent form
Pregnancy or lactation
Treatment with an investigational drug or other interventional GVHD clinical trials
Current uncontrolled bacterial, viral or fungal infection (currently taking medication with evidence of progression of clinical symptoms or radiologic findings)
Prior allogeneic HCT
Primary myelofibrosis or myelofibrosis secondary to essential thrombocythemia or polycythemia vera
Subjects with MDS may not receive RIC and must be < 50 years of age at the time of signing the informed consent form
Any condition(s) or diagnosis, both physical or psychological, or physical exam finding that in the investigator's opinion precludes participation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shannon Clark, MS
Phone
6124025362
Email
sclark2@nmdp.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffery Auletta, MD
Organizational Affiliation
Center for International Blood and Marrow Transplant Research
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
36402456
Citation
Johnstone BH, Woods JR, Goebel WS, Gu D, Lin CH, Miller HM, Musall KG, Sherry AM, Bailey BJ, Sims E, Sinn AL, Pollok KE, Spellman S, Auletta JJ, Woods EJ. Characterization and Function of Cryopreserved Bone Marrow from Deceased Organ Donors: A Potential Viable Alternative Graft Source. Transplant Cell Ther. 2023 Feb;29(2):95.e1-95.e10. doi: 10.1016/j.jtct.2022.11.010. Epub 2022 Nov 17.
Results Reference
derived
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Cryopreserved MMUD BM With PTCy for Hematologic Malignancies
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