- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02915406
cliniMACs HUD for T Cell Depletion
August 12, 2017 updated by: Gary Kleiner, University of Miami
This protocol is designed to enable access to related or unrelated CD34 cells manufactured using the CliniMACS (Miltenyi) under the HUD designation for patients needing T cell depleted allogeneic grafts for hematopoietic stem cell transplant (HSCT).
This will include patients with inherited immunodeficiency disorders as well as patients with malignancies, bone marrow failure, and other rare diseases amenable to HSCT.
Finally, patients with poor graft function and Graft Versus Host Disease(GVHD) after a previous HSCT may require a boost of T-cell depleted donor Peripheral Blood Stem Cell (PBSCs) or bone marrow cells that are CD34 selected using the CliniMACS device ENROLLMENT BY INVITATION ONLY
Study Overview
Status
No longer available
Conditions
Intervention / Treatment
Study Type
Expanded Access
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Florida
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Miami, Florida, United States, 33136
- University of Miami
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 65 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
Inclusion Criteria:
severe combined immune deficiency need for stem cell boost
Exclusion Criteria:
n/a
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Gary Kleiner, MDPhD, University of Miami
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
September 23, 2016
First Submitted That Met QC Criteria
September 23, 2016
First Posted (Estimate)
September 27, 2016
Study Record Updates
Last Update Posted (Actual)
August 16, 2017
Last Update Submitted That Met QC Criteria
August 12, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20160472
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on x Linked Combined Immunodeficiency
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Great Ormond Street Hospital for Children NHS Foundation...UnknownX-linked Severe Combined ImmunodeficiencyUnited Kingdom
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National Institute of Allergy and Infectious Diseases...RecruitingX-linked Severe Combined Immunodeficiency (XSCID)United States
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St. Jude Children's Research HospitalNational Heart, Lung, and Blood Institute (NHLBI); Assisi Foundation; California...SuspendedSevere Combined Immunodeficiency Disease, X-linkedUnited States
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Assistance Publique - Hôpitaux de ParisCompletedX-linked Severe Combined ImmunodeficiencyFrance
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David WilliamsActive, not recruitingGene Therapy | Severe Combined Immunodeficiency, X LinkedUnited States, United Kingdom
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National Institute of Allergy and Infectious Diseases...TerminatedGrowth Failure | X-linked Severe Combined Immunodeficiency (XSCID) | Growth Hormone ResistenceUnited States
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Great Ormond Street Hospital for Children NHS Foundation...RecruitingSevere Combined Immunodeficiency, X-LinkedUnited Kingdom
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National Institute of Allergy and Infectious Diseases...UnknownX-Linked Combined Immunodeficiency DiseasesUnited States
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National Institute of Allergy and Infectious Diseases...CompletedSevere Combined ImmunodeficiencyUnited States
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Children's Hospital of Chongqing Medical UniversityRecruiting
Clinical Trials on CliniMACs
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Neena Kapoor, M.D.Not yet recruitingAcute Myeloid Leukemia | Acute Lymphoblastic Leukemia | Hematologic Malignancy | Graft Vs Host Disease | Graft-versus-host-disease | Non-hematologic Malignancy
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Christopher DvorakRecruitingGraft Vs Host Disease | Graft-versus-host-diseaseUnited States
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University of Colorado, DenverNot yet recruitingHematologic Malignancy | Pediatric Patients | Other Hematologic ConditionUnited States
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Baylor College of MedicineThe Methodist Hospital Research Institute; Center for Cell and Gene Therapy...RecruitingHaploidentical Hematopoietic Cell Transplantation Using TCR Alpha/Beta and CD19 Depletion (HAPLOTAB)Myelodysplastic Syndromes | Primary Immunodeficiency Diseases | Hemoglobinopathies | Chronic Myeloid Leukemia | Cytopenia | Severe Aplastic Anemia | Bone Marrow Failure Syndrome | Acute Myeloid Leukemia in Remission | Hemophagocytic Lymphohistiocytoses | Acute Lymphoblastic Leukemia in Remission | Severe...United States
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Children's Hospital of PhiladelphiaRecruitingParoxysmal Nocturnal Hemoglobinuria | Acquired Aplastic Anemia | Inherited Bone Marrow Failure SyndromesUnited States
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Timothy OlsonActive, not recruitingSickle Cell Disease | Thalassemia MajorUnited States
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Children's Hospital of PhiladelphiaRecruitingLeukemia | Bone Marrow Failure Syndromes | Immunodeficiencies | Inborn Errors of Metabolism | Immunodysregulation Polyendocrinopathy Enteropathy X-linked SyndromeUnited States
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Joanne Kurtzberg, MDDuke University; Miltenyi Biotec, Inc.AvailableHematologic Malignancies | Immune Deficiencies | Inborn Errors of Metabolism DisordersUnited States
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Wake Forest University Health SciencesTerminatedAcute Myeloid Leukemia | Acute Lymphoblastic Leukemia | Chronic Myeloid Leukemia | Myelodysplastic Syndrome | Immune Deficiency | Lymphomas | Bone Marrow Failure | Osteopetrosis | HemoglobinopathyUnited States
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Ginna LaportTerminatedAcute 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 | Non-Hodgkin's Lymphoma (NHL) | Chronic Lymphocytic Leukemia...United States