CliniMACS® CD34+ Reagent System for Expanded Access Use

Study Overview
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Brief Summary
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CliniMACs is an investigational device used to select and enrich stem cells. The device will select the stem cells with CD34+ protein. The participant will be infused with the CD34+ selected cells in the hopes that it will help the participant engraft. Engraftment is when transplanted stem cells resume production of healthy blood cells.

Detailed Description
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After the screening procedures confirm that the participant is eligible to participate in the research study: If the participant takes part in this research study, the participant (and their donor) will have the following tests and procedures: Donor Graft Collection: The participant's cell donor will undergo stem cell collection. The cells collected will be sent to the laboratory for processing. Donor Graft Processing: In the laboratory the CliniMACS device will be used to separate the CD34+ stem cells from the other types of cells in the graft. After completing the necessary safety tests, the CD34+ selected donor graft will be ready for administration. Donor Graft Infusion: The CD34+ selected donor graft will be infused through an intravenous (I.V.) catheter. The day of this infusion is called Day 0. Follow-Up Visits: Approximately 3, 6 and 12 months after the donor graft infusion, the participant will return to clinic for follow-up visits. At each of the visits, the participant will have a physical exam and asked questions about your general health. The participant will also have routine blood tests performed (approximately 1 tablespoon of blood). At times more cells are collected from a donation than are needed to do the transplantation. If your physician determines that it is preferable to administer a dose of cells that is less than the complete collection, the extra cells may be frozen and stored in our freezers for the participant's future use. If the cell counts do not improve, the participant will be given the remaining cells through an intravenous (I.V.) catheter.

Official Title
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CliniMACS® CD34+ Reagent System for Expanded Access Use

Conditions
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Graft-Versus-Host Disease(GVHD), Anemia Due to Disturbance of Proliferation and/or Differentiation of Hematopoietic Stem Cells, Graft Failure, Delayed Graft Function

Intervention / Treatment
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* Device: CliniMACS CD34 Reagent System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged >18 years Diagnosis is graft exhaustion. Ability to understand and willingness to sign a written informed consent document Matched related or unrelated donor must consent to provide an allograft. Exclusion Criteria: Symptomatic or uncontrolled cardiac failure or coronary artery disease. Karnofsky performance status < 60%.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: CliniMACS CD34 Reagent System|Following screening and enrollment, peripheral blood or bone marrow collection will be performed on the donor followed by subsequent CD34+ cell selection using the Miltenyi CliniMACS device. There is no limit to the number of CD34+ progenitors that can be administered. The CD34+ selected cells will be infused within 12 hours of the initiation of processing.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Graft-Versus-Host Disease(GVHD), Hematopoietic Stem Cell Transplantation., Graft failure, Graft exhaustion