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To reduce the number of donors treated with IV AMD3100 who require a second collection to obtain the minimum cells necessary for allogeneic stem cell transplant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 - Donor | Experimental |
|
|
| Arm 2 - Recipient | Experimental | Standard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM Day 0 = Stem Cell Transplant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMD3100 | Drug |
|
| |
| Leukopheresis |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Donors Treated With IV AMD3100 Who Required a Second Collection to Obtain the Minimum CD34/kg (2 X 106) Necessary for Allogeneic Stem Cell Transplant | Completion of enrollment of all donors (17 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Donors Who Experience Grade 3-4 Infusional Toxicity | Up to Day 2 | |
| Number of Recipients Who Have Neutrophil Engraftment | Day 21 | |
| Pharmacokinetics of IV AMD3100 as Measured by the Mean Maximum Plasma Concentration (Cmax) |
Not provided
Inclusion Criteria:
Donor Eligibility
Recipient Eligibility
Recipient must have available the successful collection of an AMD3100 mobilized product. When an adequate collection cannot be obtained using G-CSF, some recipients may need to receive a combined product of mobilized cells with AMD3100 and g granulocyte-colony stimulating factor (G-CSF). Recipients who receive less than 2.0 X 106 CD34+ cells/kg/actual recipient weight after two days of IV AMD3100 will not be considered "eligible" but followed per protocol for safety purposes only.
Patient is 18 to 65 years of age inclusive.
Patient is willing and has a 6/6 HLA-matched sibling willing to donate PBSC for transplant.
Patient must provide signed informed consent.
If female and of child-bearing age: must be non-pregnant, not breast feeding, and uses adequate contraception.
Patient must have one of the following diagnoses:
Adequate cardiac function with a left ventricular ejection fraction ≥ 40%.
Adequate pulmonary function defined as NO severe or symptomatic restrictive or obstructive lung disease, and formal pulmonary function testing showing an FEV1 ≥50% of predicted and a DLCO ≥40% of predicted, corrected for hemoglobin.
Adequate renal function as defined by a serum creatinine clearance of ≥75% of normal (Cockcroft-Gault equation).
Adequate hepatic function as defined by a total bilirubin <2x normal or absence of hepatic fibrosis/cirrhosis.
Adequate neurologic function as defined by NO evidence of a severe central or peripheral neurologic abnormality. Patients with a history of previous central nervous system (CNS) tumor involvement are eligible provided they are without symptoms or signs and the CNS is now free of disease on lumbar puncture and CT scan of the brain.
No evidence of active infection at the time of the transplant preparative regimen or at time of transplantation.
Patient must be HIV-1&2 antibody and HTLV-I & II antibody sero-negative, by FDA licensed test.
Patient has an ECOG performance status of 0 or 1.
Patient must demonstrate ability to be compliant with medical regimen.
Patient must not have active alcohol or substance abuse within 6 months of study entry.
Patient must not be enrolled on another investigational agent concurrently.
Patient must not have any medical condition, which, in the opinion of the clinical investigator, would interfere with the evaluation of the patient.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John DiPersio, M.D., Ph.D. | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12531874 | Background | Levesque JP, Hendy J, Takamatsu Y, Simmons PJ, Bendall LJ. Disruption of the CXCR4/CXCL12 chemotactic interaction during hematopoietic stem cell mobilization induced by GCSF or cyclophosphamide. J Clin Invest. 2003 Jan;111(2):187-96. doi: 10.1172/JCI15994. | |
| 9933168 | Background | Peled A, Petit I, Kollet O, Magid M, Ponomaryov T, Byk T, Nagler A, Ben-Hur H, Many A, Shultz L, Lider O, Alon R, Zipori D, Lapidot T. Dependence of human stem cell engraftment and repopulation of NOD/SCID mice on CXCR4. Science. 1999 Feb 5;283(5403):845-8. doi: 10.1126/science.283.5403.845. |
| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
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The study opened to participant enrollment on 08/12/2009 and closed to participants enrollment on 01/31/2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1 - Donor |
|
| FG001 | Arm 2 - Recipient | Standard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM Day 0 = Stem Cell Transplant |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
One recipient was not transplanted because of donor withdrawal of consent to collect a second day after a failed first day apheresis attempt.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1 - Donor |
|
| BG001 | Arm 2 - Recipient |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Donors Treated With IV AMD3100 Who Required a Second Collection to Obtain the Minimum CD34/kg (2 X 106) Necessary for Allogeneic Stem Cell Transplant | 3 donors failed to reach target after two collections and 1 donor withdrew consent after failing to reach the goal on the first collection. | Posted | Number | participants | Completion of enrollment of all donors (17 months) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1 - Donor |
|
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal cramping | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John DiPersio, M.D., Ph.D. | Washington University School of Medicine | 314-454-8304 | jdipersi@dom.wustl.edu |
Not provided
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C088327 | plerixafor |
| D007937 | Leukapheresis |
| D033581 | Stem Cell Transplantation |
| ID | Term |
|---|---|
| D016238 | Cytapheresis |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D001781 | Blood Component Removal |
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| Procedure |
|
| Stem cell transplant | Procedure |
|
-Blood samples for pharmacokinetics were drawn on the following schedule:
|
| Day 1 and Day 2 |
| Pharmacokinetics of IV AMD3100 as Measured by Half Life | -Blood samples for pharmacokinetics were drawn on the following schedule:
| Day 1 and Day 2 |
| Pharmacokinetics of IV AMD3100 as Measured by Mean Area Under Curve (AUC) | Day 1 and Day 2 |
| Rate of Acute GVHD (Grade II-IV) in Recipients | Day 0-Day 100 (acute) |
| Rate of Acute GVHD (Grade III-IV) in Recipients | Day 0-Day 100 (acute) |
| Time to Neutrophil Engraftment for Recipients | Measured by determine the first 3 consecutive measurement of neutrophil count = 500/ul following conditioning regimen induced nadir. | Up through Day 100 |
| Time to Platelet Engraftment for Recipients | Measured by determining the first of 3 consecutive measurements of platelet count = 20,000/ul without platelet transfusion support for 7 days. | Up to Day 100 |
| Transplant Related Mortality Rate for Recipients | Death that results from a transplant procedure related complication rather than from relapse of the underlying disease or unrelated cause. | Day 100 |
| Grade 3-4 Toxicity for Recipients | Assessed and graded according to NCI Common Terminology for Adverse Events Version 3.0. | 1 year |
| Rate of Chronic GVHD in Recipients | Day 101-1 year |
| Number of Donors Who Experience Grade 3-4 Mobilization Toxicity Due to Pheresis Procedure | Up to Day 2 |
| Background | Broxmeyer HE, Hangoc G, Cooper S, Bridger G. Interference of the SDF-1/CXCR4 axis in mice with AMD3100 induces rapid high level mobilization of hematopoietic progenitor cells, and AMD3100 acts synergistically with G-CSF and MIP-1 alpha to mobilize progenitors. Blood. 2001;96:3371a |
| Background | Broxmeyer HE, Hangoc G, Cooper S, Li X, Bridger G, Clapp DW. AMD3100, an antagonist of CXCR4 and mobilizer of myeloid progenitor cells, is a potent mobilizer of competitive repopulating long term marrow self renewing stem cells in mice. Blood. 2002;98:2397a |
| 12855591 | Background | Liles WC, Broxmeyer HE, Rodger E, Wood B, Hubel K, Cooper S, Hangoc G, Bridger GJ, Henson GW, Calandra G, Dale DC. Mobilization of hematopoietic progenitor cells in healthy volunteers by AMD3100, a CXCR4 antagonist. Blood. 2003 Oct 15;102(8):2728-30. doi: 10.1182/blood-2003-02-0663. Epub 2003 Jul 10. |
| Background | Devine S, Adkins D, Khoury H, Vij R, Goodnough LT, Graubert T, Tomasson M, Blum W, DiPersio J, Brown R. Mobilization of donors with GM-CSF plus G-CSF or GM-CSF alone results in significantly different graft composition compared to G-CSF alone. Blood. 2002;100:825a |
| 18426988 | Background | Devine SM, Vij R, Rettig M, Todt L, McGlauchlen K, Fisher N, Devine H, Link DC, Calandra G, Bridger G, Westervelt P, Dipersio JF. Rapid mobilization of functional donor hematopoietic cells without G-CSF using AMD3100, an antagonist of the CXCR4/SDF-1 interaction. Blood. 2008 Aug 15;112(4):990-8. doi: 10.1182/blood-2007-12-130179. Epub 2008 Apr 21. |
| 15837815 | Background | Broxmeyer HE, Orschell CM, Clapp DW, Hangoc G, Cooper S, Plett PA, Liles WC, Li X, Graham-Evans B, Campbell TB, Calandra G, Bridger G, Dale DC, Srour EF. Rapid mobilization of murine and human hematopoietic stem and progenitor cells with AMD3100, a CXCR4 antagonist. J Exp Med. 2005 Apr 18;201(8):1307-18. doi: 10.1084/jem.20041385. |
| 17382247 | Background | Hess DA, Bonde J, Craft TP, Wirthlin L, Hohm S, Lahey R, Todt LM, Dipersio JF, Devine SM, Nolta JA. Human progenitor cells rapidly mobilized by AMD3100 repopulate NOD/SCID mice with increased frequency in comparison to cells from the same donor mobilized by granulocyte colony stimulating factor. Biol Blood Marrow Transplant. 2007 Apr;13(4):398-411. doi: 10.1016/j.bbmt.2006.12.445. |
| 28292947 | Derived | Schroeder MA, Rettig MP, Lopez S, Christ S, Fiala M, Eades W, Mir FA, Shao J, McFarland K, Trinkaus K, Shannon W, Deych E, Yu J, Vij R, Stockerl-Goldstein K, Cashen AF, Uy GL, Abboud CN, Westervelt P, DiPersio JF. Mobilization of allogeneic peripheral blood stem cell donors with intravenous plerixafor mobilizes a unique graft. Blood. 2017 May 11;129(19):2680-2692. doi: 10.1182/blood-2016-09-739722. Epub 2017 Mar 14. |
Standard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM
Day 0 = Stem Cell Transplant
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Number of Donors Who Experience Grade 3-4 Infusional Toxicity | Posted | Number | participants | Up to Day 2 |
|
|
|
| Secondary | Number of Recipients Who Have Neutrophil Engraftment | Posted | Number | participants | Day 21 |
|
|
|
| Secondary | Pharmacokinetics of IV AMD3100 as Measured by the Mean Maximum Plasma Concentration (Cmax) | -Blood samples for pharmacokinetics were drawn on the following schedule:
| Posted | Mean | Standard Deviation | ng/mL | Day 1 and Day 2 |
|
|
|
| Secondary | Pharmacokinetics of IV AMD3100 as Measured by Half Life | -Blood samples for pharmacokinetics were drawn on the following schedule:
| Posted | Mean | Standard Deviation | hours | Day 1 and Day 2 |
|
|
|
| Secondary | Pharmacokinetics of IV AMD3100 as Measured by Mean Area Under Curve (AUC) | Posted | Mean | Standard Deviation | hr.ng/mL | Day 1 and Day 2 |
|
|
|
| Secondary | Rate of Acute GVHD (Grade II-IV) in Recipients | Posted | Number | participants | Day 0-Day 100 (acute) |
|
|
|
| Secondary | Rate of Acute GVHD (Grade III-IV) in Recipients | Posted | Number | participants | Day 0-Day 100 (acute) |
|
|
|
| Secondary | Time to Neutrophil Engraftment for Recipients | Measured by determine the first 3 consecutive measurement of neutrophil count = 500/ul following conditioning regimen induced nadir. | Posted | Median | Full Range | days | Up through Day 100 |
|
|
|
| Secondary | Time to Platelet Engraftment for Recipients | Measured by determining the first of 3 consecutive measurements of platelet count = 20,000/ul without platelet transfusion support for 7 days. | Posted | Median | Full Range | days | Up to Day 100 |
|
|
|
| Secondary | Transplant Related Mortality Rate for Recipients | Death that results from a transplant procedure related complication rather than from relapse of the underlying disease or unrelated cause. | Posted | Number | participants | Day 100 |
|
|
|
| Secondary | Grade 3-4 Toxicity for Recipients | Assessed and graded according to NCI Common Terminology for Adverse Events Version 3.0. | Posted | Number | participants | 1 year |
|
|
|
| Secondary | Rate of Chronic GVHD in Recipients | 8 patients are not evaluable because they were not alive for the outcome measure time frame. | Posted | Number | participants | Day 101-1 year |
|
|
|
| Secondary | Number of Donors Who Experience Grade 3-4 Mobilization Toxicity Due to Pheresis Procedure | Posted | Number | participants | Up to Day 2 |
|
|
|
| 0 |
| 33 |
| 33 |
| 33 |
| EG001 | Arm 2 - Recipient | Standard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM Day 0 = Stem Cell Transplant | 0 | 33 | 33 | 33 |
| Adult respiratory distress | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Bacteremia | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Catheter site infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Catheter site pain | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Chest pain | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| Cold sensation | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Congestive heart failure | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Distension/abdominal bloating | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Febrile neutropenia | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Fever | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| GI fistula | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Generalized weakness | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hand tremor | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hematuria | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hot flashes | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hyperbiluribinemia | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypotension | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
| Incontinence | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Increase transaminase | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
|
| Leg pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Lightheadedness | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Lower extremities edema | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Mental status change | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
|
| Mucositis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Parotiditis | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Purpura | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Sensory neuropathy | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Sinus bradycardia | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| Skin nodules | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Sweating (diaphoresis) | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| Throat pain | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Thrombocytopenia | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Thrombosis/embolism (DVT) | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
| Upper respiratory infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Urinary frequency/urgency | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Vasovagal episode | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Warm sensation | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Weight loss | Investigations | CTCAE (3.0) | Systematic Assessment |
|
Not provided
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| D047589 |
| Leukocyte Reduction Procedures |
| D002469 | Cell Separation |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D008919 | Investigative Techniques |
| D017690 | Cell Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
| Title | Measurements |
|---|---|
|
| Grade 3 GI fistula |
|
| Grade 3 increased transaminase |
|
| Grade 3 febrile neutropenia |
|
| Grade 3 bacteremia+ |
|
| Grade 3 respiratory distress |
|
| Grade 3 renal failure |
|