N/A N=70 Evaluation of the Spectra Optia® Apheresis System Mononuclear Cell (MNC) Collection Procedure in Healthy Blood Donors
Leukapheresis
Primary: Mononuclear Cell Collection Efficiency — 61; 57 % of processed MNCs that were collected
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
N/A N=77 Clinical Evaluation of the CM-1500 During Apheresis Blood Donation
Fluid Loss
Primary: Characterize Changes in the Relative Index During an Apheresis Procedure — 94.9; 99.3 Relative Index
Phase 1 N=170 Evaluation of Whole Blood With CPD Anticoagulant and AS-7/SOLX Additive Solution
Blood Donors
Primary: Red Blood Cell Post-filtration Recovery — 92.57; 92.70; 90.96; 90.23 % recovery at day 0
N/A N=22 Survival and Recovery of Radio-labeled Platelets Derived From Mirasol-treated Whole Blood
Blood Safety
Primary: Platelet 24-hour Relative Recovery — 43.31; 52.01 Percentage of platelet count
Phase 2 N=40 Preventing Stem Cell Transplant Complications With a Blood Separator Machine
MDS (Myelodysplastic Syndrome) · Myeloproliferative Disorder · Lymphoma, Non-Hodgkin
Primary: Overall Survival — 36 Participants
Phase 2 N=8 AMD 3100 (Mozobil Plerixafor) to Mobilize Stem Cells for Donation
Healthy
Primary: Change in Cytokine Gene Expression Profiles (84 Genes) in T Cells Following G-CSF Administration — 16 unique cytokine genes affected
Phase 3 N=110 Tdap Vaccine Safety for Plasma Donors
Tetanus
Primary: Number of Participants With Treatment Emergent Adverse Events (TEAEs) — 71; 42; 0 participants
Phase 2 N=116 Methods to Enhance the Safety and Effectiveness of Stem Cell Transplants
Chronic Myelogenous Leukemia · Acute Myelogenous Leukemia · Chronic Lymphocytic Leukemia
Primary: Survival and Non-relapse Mortality at Day +200 Using the Miltenyi Reagent System — 43; 4 participants
Phase 1 N=15 Peripheral Blood Stem Cell Collection for Sickle Cell Disease (SCD) Patients
Sickle Cell Disease
Primary: Number of Participants With Sufficient Collection of Hemopoietic Stem Cells (HSCs) Without Serious Adverse Events — 14 Participants
Phase 2 N=49 Collection of Transplant Stem Cells for Plasma Cell Myeloma
Plasma Cell Myeloma · Multiple Myeloma
Primary: Percentage of Patients Achieving at Least 2 x 10^6 Cluster of Differentiation 34 (CD34) Cells Per Kg Recipient Body Weight on Day 1 of Apheresis — 98 percentage of…
Phase 2 N=73 Mismatched Family Member Donor Transplantation for Children and Young Adults With High Risk Hematological Malignancies
Leukemia, Acute Lymphocytic (ALL) · Leukemia, Myeloid, Acute(AML) · Leukemia, Myeloid, Chronic(CML)
Primary: Event-free Survival (EFS) — 54.8 Percentage of participants
N/A N=79 Donor Iron Deficiency Study - Red Blood Cells From Iron-deficient Donors: Recovery and Storage Quality
Iron Deficiency
Primary: 51-Chromium 24-hour Post-transfusion RBC Recovery of Units — 1.6; -0.4 percentage change
Phase 2 N=9 G-CSF and AMD3100 to Mobilize Stem Cells in Healthy Volunteers
Healthy
Primary: Number of Participants With Successful Apheresis Collection Following Combination of AMD3100 and G-CSF. — 8; 1 participants
N/A N=23 An Evaluation of the Spectra Optia CMNC Collection Procedure
Healthy Apheresis Donors · Mononuclear (MNC) Cell Donors
Primary: CD34+ Collection Efficiency (CE1 %) — 87.7; 81.4; 66.6; 65.8 percent
N/A N=197 Iron Depletion and Replacement in Blood Donors
Anemia
Primary: Number of Participants With Adherence to Iron Replacement Therapy at Subsequent Donation — 116; 17 Participants
Phase 2 N=46 T Cell Depletion for Recipients of HLA Haploidentical Related Donor Stem Cell Grafts
Acute Lymphoblastic Leukemia · Non Hodgkins Lymphoma · Myelodysplastic Syndrome
Primary: Engraftment Rate After Transplant — 100; 100 percentage of participants
N/A N=784 Healthcare Utilization in Obese Caregiver Living Donors
Utilization, Health Care · Obesity
Primary: Emergency Department Utilization — 77; 305 Participants
Phase 2 N=22 Plerixafor for Stem Cell Mobilization in Normal Donors
Blood And Marrow Transplantation
Primary: Summary of Most Common Toxicity: Donor Safety in Mobilizing Peripheral Blood Progenitor Cells (PBPC) — 1; 2; 2; 2 adverse events
Phase 2 N=29 Megadose CD34 Selected Progenitor Cells for Transplantation in Patients With Advanced Hematological Malignant Diseases
Leukemia · Lymphoma
Primary: Number of Participants With Absolute Neutrophil Count Engraftment — 21 participant
N/A N=3 CD34+ Cell Enriched and T Cell Depleted Allogeneic Stem Cell Transplantation for Patients With Mismatched Related Donors or Borderline Organ Function
Malignant Diseases · Non-malignant Diseases
Primary: Number of Patients With Severe (Grade III/IV) Acute Graft vs Host Disease (GVHD) — 0 Participants
Phase 2 N=68 Intravenous (IV) AMD3100 for Mobilization and Matched Related Transplant for Advanced Hematological Malignancies
Hematologic Neoplasms
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 — 10…
N/A N=4 Partially Matched Stem Cell Transplantation for Patients With Refractory Severe Aplastic Anemia or Refractory Cytopenias
Anemia, Aplastic · Amegakaryocytic Thrombocytopenia · Diamond-Blackfan Anemia
Primary: Treatment Failures
N/A N=351 Evaluation of Physiological Variables and Detection of Blood Loss Using the Zynex Fluid Monitoring System, Model CM-1600
Fluid Loss
Primary: Change in the Relative Index (RI) After Minor Blood Loss (e.g., 500mL) — 2.9 Percent change in RI
N/A N=18 (H.E.L.P.)Apheresis Therapy to Compare the Reduction of LDL (Low Density Lipoprotein) Cholesterol
Hypercholesterolemia
Primary: Percent Change in Pre- and Post-treatment Reductions of Low-density Lipoprotein Cholesterol (LDL-C) Levels Between the Approved H.E.L.P. System and the Modified H.E.L.P…
N/A N=120 Evaluation of Physiological Variables and Detection of Blood Loss in Healthy Adults With Different Subject Positioning by the CM-1500
Fluid Loss · Blood Loss
Primary: Impact of Subject Positioning on Percent Change of Heart Rate (HR) After Minor Blood Loss (e.g., 500mL) — 10.7; 14.7 percent change
N/A N=43 Data Collection of Routine Clinical Use With the Spectra Optia® Apheresis System for White Blood Cell Depletion
Leukocytosis
Primary: Percent Decrease in White Blood Cell Count in Patient Following Apheresis Procedure — 54.5 % change in subject's WBC count
N/A N=32 Evaluation of the Spectra Optia® Mononuclear Cell Collection Procedure
Multiple Myeloma
Primary: Days Until Neutrophil Recovery Following Peripheral Blood Stem Cell Transplant Minus the Historical Median Day Until Recovery. — 0 Days — p=<0.025
Phase 2 N=422 HLA-Compatible Related or Unrelated Donors With CD34+ Enriched, T-cell Depleted Peripheral Blood Stem Cells Isolated by the CliniMACS System in the Treatment of Patients With Hematologic Malignancies
Acute Lymphoblastic Leukemia · Acute Myelogenous Leukemia · Myelodysplastic Syndrome
Primary: The Incidence of Durable Hematopoietic Engraftment for T-cell Depleted Transplants Fractionated by the CliniMACS System Administered After Each of the Four Disease…
N/A N=72 Don't Throw Your Heart Away: Clinician Study 3
Cardiac Transplant Disorder
Primary: Hospital Choice — 4; 21; 34; 13 Participants
Phase 2 N=31 Stem Cell Transplant Using Peripheral and Cord Blood Stem Cells to Treat Severe Aplastic Anemia and Myelodysplastic Syndrome
Myelodysplastic Syndrome (MDS) With Refractory Anemia (RA) · Severe Aplastic Anemia (SAA)
Primary: Number of Participants Who Engrafted by Day 42 — 30 Participants