{"id":"clinimacs-cd34-reagent-system","_chembl":{"chemblId":"CHEMBL5315093","moleculeType":"Unknown"},"modality":"Biologic","_dailymed":null,"mechanism":{"target":"CD34","explanation":"The system uses magnetic microbeads conjugated to antibodies that bind to the CD34 surface antigen expressed on hematopoietic stem and progenitor cells. Cells are passed through a magnetic field that retains CD34-positive cells while allowing other cells to pass through, enabling enrichment of stem cell populations for transplantation.","oneSentence":"Magnetic bead-based cell selection system that isolates CD34-positive hematopoietic stem and progenitor cells using immunomagnetic separation technology."},"_scrapedAt":"2026-03-28T03:08:15.162Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"_claudeStub":{"ts":1779123803,"model":"claude-sonnet-4-5-20250929"},"competitors":[{"name":"Isolex 300i Magnetic Cell Selection System","brand":"Isolex","company":"Baxter Healthcare","rationale":"Magnetic bead-based CD34+ cell selection system for stem cell processing"}],"description":"CliniMACS CD34 Reagent System is a cell selection technology used to isolate CD34-positive hematopoietic stem and progenitor cells from various sources. It is primarily used in stem cell transplantation procedures and regenerative medicine applications to enrich stem cell populations for therapeutic use.","indications":{"approved":[{"status":"investigational","condition":"Hematopoietic stem cell transplantation","patientPopulation":"Pediatric and adult patients requiring stem cell selection"}]},"trialDetails":[{"nctId":"NCT03173937","phase":"PHASE1, PHASE2","title":"Unrelated Umbilical Cord Blood Transplantation for Severe Aplastic Anemia and Hypo-plastic MDS Using CordIn(TM), Umbilical Cord Blood-Derived Ex Vivo Expanded Stem and Progenitor Cells to Expedite Engraftment and Improve Transplant Outcome","status":"RECRUITING","sponsor":"National Heart, Lung, and Blood Institute (NHLBI)","startDate":"2017-06-13","conditions":"Severe Aplastic Anemia, Hypo-Plastic MDS, Myelodysplastic Syndrome (MDS)","enrollment":37},{"nctId":"NCT03538899","phase":"PHASE1, PHASE2","title":"Autologous Gene Therapy for Artemis-Deficient SCID","status":"RECRUITING","sponsor":"University of California, San Francisco","startDate":"2018-05-31","conditions":"Severe Combined Immunodeficiency","enrollment":24},{"nctId":"NCT01174108","phase":"PHASE2","title":"Allogeneic Hematopoietic Stem Cell Transplantation for Severe Aplastic Anemia and Other Bone Marrow Failure Syndromes Using G-CSF Mobilized CD34+ Selected Hematopoietic Precursor Cells Co-Infused With a Reduced Dose of Non-Mobilized Donor T-cells","status":"RECRUITING","sponsor":"National Heart, Lung, and Blood Institute (NHLBI)","startDate":"2010-12-10","conditions":"Severe Aplastic Anemia, MDS (Myelodysplastic Syndrome)","enrollment":120},{"nctId":"NCT03626285","phase":"","title":"Bone Marrow Transplantation Using CD34-Selected Stem Cells From Related or Unrelated Donors in Treating Participants With Cancer or Other Disorders","status":"AVAILABLE","sponsor":"OHSU Knight Cancer Institute","startDate":"","conditions":"Benign Neoplasm, Bone Marrow Transplantation Recipient, Hematopoietic Cell Transplantation Recipient","enrollment":""},{"nctId":"NCT05088356","phase":"PHASE1","title":"Reduced Intensity Allogeneic HCT in Advanced Hematologic Malignancies w/T-Cell Depleted Graft","status":"RECRUITING","sponsor":"Stanford University","startDate":"2021-09-07","conditions":"Allogeneic Hematopoietic Cell Transplantation (HCT), Advanced Hematologic Malignancies, Acute Leukemia","enrollment":60},{"nctId":"NCT01189786","phase":"NA","title":"Ex Vivo T-Cell Depletion of Mobilized Peripheral Blood Stem Cells Via CD34-Selection","status":"RECRUITING","sponsor":"Baylor College of Medicine","startDate":"2010-10","conditions":"Stem Cell Transplant, Allogeneic","enrollment":241},{"nctId":"NCT01881334","phase":"","title":"Expanded Access to T-cell Depleted Haplo-Identical Stem Cells for Patients Receiving Haplo-Identical and Unrelated Cord Blood Transplants","status":"AVAILABLE","sponsor":"Joanne Kurtzberg, MD","startDate":"","conditions":"Hematologic Malignancies, Inborn Errors of Metabolism Disorders, Immune Deficiencies","enrollment":""},{"nctId":"NCT06569082","phase":"NA","title":"CD34+ Selected Stem Cell for Poor Graft Function or Graft Failure","status":"RECRUITING","sponsor":"NYU Langone Health","startDate":"2024-10-31","conditions":"Graft Failure, Poor Graft Function","enrollment":21},{"nctId":"NCT01810588","phase":"PHASE2","title":"Targeting the IPA and Matching for the Non-Inherited Maternal Antigen for Haplo-Cord Transplantation","status":"ACTIVE_NOT_RECRUITING","sponsor":"Weill Medical College of Cornell University","startDate":"2012-10-16","conditions":"Hematologic Malignancies","enrollment":270},{"nctId":"NCT03093844","phase":"NA","title":"Haploidentical CD34+ Selected Cells Combined With Single Unit Umbilical Cord Blood Transplant for Treatment of High-risk Hematologic Disorders","status":"COMPLETED","sponsor":"University of Colorado, Denver","startDate":"2017-10-12","conditions":"Hematologic Disorders","enrollment":150},{"nctId":"NCT01966367","phase":"PHASE1, PHASE2","title":"CD34+ (Non-Malignant) Stem Cell Selection for Patients Receiving Allogeneic Stem Cell Transplantation","status":"ACTIVE_NOT_RECRUITING","sponsor":"Diane George","startDate":"2013-03","conditions":"Bone Marrow Failure Syndrome, Severe Aplastic Anemia, Severe Congenital Neutropenia","enrollment":37},{"nctId":"NCT05968170","phase":"NA","title":"TCRαβ/CD19 Depletion of Stem Cell Grafts for Transplant","status":"WITHDRAWN","sponsor":"Neena Kapoor, M.D.","startDate":"2025-05-27","conditions":"Graft Vs Host Disease, Graft-versus-host-disease, Acute Myeloid Leukemia","enrollment":""},{"nctId":"NCT06986382","phase":"PHASE1, PHASE2","title":"Phase 1b/2a Trial of Allogeneic HSCT From an HLA-partially Matched Related or Unrelated Donor After TCRab+ T-cell/CD19+ B-cell Depletion for Patients With Monogenic and/or Early-onset Medically Refractory Crohn Disease","status":"NOT_YET_RECRUITING","sponsor":"Stanford University","startDate":"2025-07","conditions":"Crohn Disease","enrollment":14},{"nctId":"NCT01660347","phase":"NA","title":"Donor Stem Cell Boost in Treating Patients With Low Blood Cells After Donor Stem Cell Transplant","status":"WITHDRAWN","sponsor":"Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University","startDate":"2012-08","conditions":"Anemia, Hematopoietic/Lymphoid Cancer, Lymphopenia","enrollment":""},{"nctId":"NCT04337515","phase":"NA","title":"A Feasibility Study Using CLINIMACS® for Alpha/Beta T-Cell Depletion in Stem Cell Transplant","status":"RECRUITING","sponsor":"Christopher Dvorak","startDate":"2019-12-19","conditions":"Graft Vs Host Disease, Graft-versus-host-disease","enrollment":90},{"nctId":"NCT04804891","phase":"PHASE1","title":"Using T-Cell Alloreactivity and Chimerism to Guide Immunosuppression Minimization in Intestinal Transplantation","status":"RECRUITING","sponsor":"Columbia University","startDate":"2021-10-22","conditions":"Intestinal Transplantation","enrollment":6},{"nctId":"NCT02158767","phase":"","title":"Access Protocol. Infusion of CD34+ Enriched, T Cell Depleted Hematopoietic Stem Cell Grafts.","status":"NO_LONGER_AVAILABLE","sponsor":"Leland Metheny","startDate":"","conditions":"Hematopoietic/Lymphoid Cancer","enrollment":""},{"nctId":"NCT05288595","phase":"PHASE2","title":"TCR Alpha/Beta and CD19-deplete Haplo-HSCT","status":"WITHDRAWN","sponsor":"University of Colorado, Denver","startDate":"2024-12","conditions":"Pediatric Patients, Hematologic Malignancy, Other Hematologic Condition","enrollment":""},{"nctId":"NCT01639690","phase":"PHASE1","title":"ß-Thalassemia Major with Autologous CD34+ Hematopoietic Progenitor Cells Transduced with TNS9.3.55 a Lentiviral Vector Encoding the Normal Human ß-Globin Gene","status":"ACTIVE_NOT_RECRUITING","sponsor":"San Rocco Therapeutics","startDate":"2012-07","conditions":"Confirmed Diagnosis of ß-thalassemia Major","enrollment":10},{"nctId":"NCT02061800","phase":"PHASE1, PHASE2","title":"CD34+ (Malignant) Stem Cell Selection for Patients Receiving Allogenic Stem Cell Transplant","status":"ACTIVE_NOT_RECRUITING","sponsor":"Diane George","startDate":"2013-06-03","conditions":"Chronic Myeloid Leukemia (CML), Acute Myelogenous Leukemia (AML), Myelodysplastic Syndrome (MDS)","enrollment":14},{"nctId":"NCT05508009","phase":"PHASE1, PHASE2","title":"Early Trial of Allogeneic Hematopoietic Stem Cell Transplantation for Patients Who Will Receive a Kidney Transplant From the Same Donor","status":"RECRUITING","sponsor":"Alice Bertaina","startDate":"2023-01-10","conditions":"SIOD, Cystinosis, FSGS","enrollment":12},{"nctId":"NCT01596257","phase":"PHASE2","title":"Bulk Versus Fractionated Stem Cell Infusions in Patients With Hematologic Malignancies Undergoing Stem Cell Transplantation","status":"COMPLETED","sponsor":"Memorial Sloan Kettering Cancer Center","startDate":"2012-05-05","conditions":"Leukemia","enrollment":116},{"nctId":"NCT03717480","phase":"PHASE2","title":"Ex Vivo TCR αβ T Cell Depletion for Graft-Versus-Host Disease Prophylaxis in Mismatched Donor Peripheral Blood Stem Cell Transplantation for Hematologic Malignancies","status":"TERMINATED","sponsor":"Dana-Farber Cancer Institute","startDate":"2020-01-21","conditions":"Hematologic Malignancy","enrollment":2},{"nctId":"NCT00378534","phase":"PHASE2","title":"Methods to Enhance the Safety and Effectiveness of Stem Cell Transplants","status":"COMPLETED","sponsor":"National Heart, Lung, and Blood Institute (NHLBI)","startDate":"2006-09","conditions":"Chronic Myelogenous Leukemia, Acute Myelogenous Leukemia, Chronic Lymphocytic Leukemia","enrollment":116},{"nctId":"NCT01598025","phase":"NA","title":"Biparental HLA Haplotype Disparate T-cell Depleted Transplants for Patients Lacking an HLACompatible Donor","status":"TERMINATED","sponsor":"Memorial Sloan Kettering Cancer Center","startDate":"2012-05-02","conditions":"Acute Leukemia, Chronic Leukemia, Myelodysplastic Syndrome","enrollment":3},{"nctId":"NCT01745913","phase":"PHASE2","title":"Randomized HaploCord Blood Transplantation vs. Double Umbilical Cord Blood Transplantation for Hematologic Malignancies","status":"TERMINATED","sponsor":"Weill Medical College of Cornell University","startDate":"2012-10-26","conditions":"Acute Myelogenous Leukemia, Myelodysplastic Syndrome, Acute Lymphocytic Leukemia","enrollment":2},{"nctId":"NCT01050764","phase":"PHASE1, PHASE2","title":"Haploidentical Allogeneic Transplant With Post-transplant Infusion of Regulatory T-cells","status":"TERMINATED","sponsor":"Everett Meyer","startDate":"2009-06","conditions":"Leukemia, Acute, Chronic Myelogenous Leukemia (CML), Myelodysplastic Syndrome (MDS)","enrollment":10},{"nctId":"NCT02199041","phase":"PHASE2","title":"Combined T Cell Depleted Haploidentical Peripheral Blood Stem Cell and Unrelated Umbilical Cord Blood Transplantation in Patients With Hematologic Malignancies Using a Total Lymphoid Irradiation Based Preparative Regimen","status":"TERMINATED","sponsor":"St. Jude Children's Research Hospital","startDate":"2014-07-11","conditions":"Hematological Malignancies","enrollment":24},{"nctId":"NCT02026934","phase":"","title":"CliniMACS® CD34+ Reagent System for Expanded Access Use","status":"NO_LONGER_AVAILABLE","sponsor":"Joseph Antin","startDate":"2013-03","conditions":"Graft-Versus-Host Disease(GVHD), Anemia Due to Disturbance of Proliferation and/or Differentiation of Hematopoietic Stem Cells, Graft Failure","enrollment":""},{"nctId":"NCT00569179","phase":"PHASE1","title":"A Phase I Trial of Alloreactive Cell Infusion Following Transplantation of Haplotype Cells in Patients With Myeloid Malignancies","status":"TERMINATED","sponsor":"Indiana University School of Medicine","startDate":"2007-08","conditions":"Leukemia, Myeloid, Acute, Leukemia, Lymphoid, Myelodysplastic Syndromes","enrollment":1},{"nctId":"NCT00185679","phase":"PHASE2","title":"Haploid Allogeneic Transplant Using the CliniMACS System","status":"TERMINATED","sponsor":"Ginna Laport","startDate":"2001-11","conditions":"Acute Myelogenous Leukemia (AML) - Relapsed, Primary Refractory Disease or Poor Risk Factors, Chronic Myelogenous Leukemia (CML) - Accelerated or Second Chronic Phase, Myelodysplastic Syndrome (MDS) - High and Intermediate Risk","enrollment":13}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_2","status":"active","brandName":"CliniMACS CD34 Reagent System","genericName":"CliniMACS CD34 Reagent System","companyName":"Joanne Kurtzberg, MD","companyId":"joanne-kurtzberg-md","firstApprovalDate":"","aiSummary":"The CliniMACS CD34 Reagent System is used in conjunction with the CliniMACS Plus Instrument to select and enrich CD34+ cells, which are then transduced with a retroviral vector encoding the human ADA cDNA sequence. This system is used in clinical trials for various hematologic conditions, including hematologic malignancy, graft failure, and poor graft function, to treat patients with a T-cell depleted allogeneic hematopoietic cell transplant.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":2,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":false,"trials":true,"score":3}}