Compassionate Access of the Miltenyi Device for CD34+ Cell Selection

Study Overview
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Brief Summary
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Objectives: Primary Objective To provide compassionate access to the Miltenyi device for CD34+ cell infusions to patients who experience poor graft function after stem cell transplantation (SCT).

Detailed Description
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The therapy that you will receive involves you being given an infusion of CD34 positive stem cells. Below is a detailed explanation of the therapeutic procedures that will be performed. CD34 positive stem cells infusion: The CD34 positive stem cells are collected from a donor's blood. The blood cells go through CD34 (stem cell) selection process that collects the stem cells that are needed for the infusion. This process collects the early immune cells your body will need to regrow your immune system, and makes sure that other cells will not be infused. This process will decrease (but not eliminate completely) the other types of cells. If you agree to receive this treatment, the CD34 cells will then be infused into your body. The CD34 positive cells will be given by vein in either an inpatient or outpatient treatment area. The infusion will last about 10-30 minutes. Before the infusion, you will receive Tylenol (acetaminophen) by mouth and Benadryl (diphenhydramine hydrochloride) by mouth or vein about 30-60 minutes before the infusion. These drugs will be used to help lower the risk of side effects. If side effects occur during the infusion, the doses of the drugs may be adjusted (up or down) until the symptoms are gone. Also, if you have side effects during the infusion, you will be observed for 2 hours after it is given or until the symptoms have stopped completely (whichever is later). During this time, your blood pressure, heart rate, breathing rate, temperature, and the level of oxygen in your blood will be checked every 15-30 minutes. About 4-6 weeks after the first infusion, you may receive an additional infusion, if your doctor thinks it is needed. Clinic Visits: One (1) time a week after the infusion, until your doctor thinks it is no longer clinically needed, you will have the following tests: Blood (about 1 teaspoon) will be drawn for routine tests. You will be checked for signs of graft versus host disease (GVHD). Symptoms of GVHD include skin rash, nausea, vomiting, diarrhea, and abnormal liver function. This is an investigational study. The CD34 positive stem cell infusion to help boost cell counts is not FDA approved. Up to 75 patients will be enrolled on this treatment.

Official Title
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Compassionate Access of the Miltenyi Device for CD34+ Cell Selection

Conditions
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Blood And Marrow Transplantation

Intervention / Treatment
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* Biological: CD34 Positive Stem Cell Infusion
* Device: Miltenyi device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1) Patients who have poor or no graft function post stem cell transplantation. Exclusion Criteria: N/A
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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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CD34 Positive Stem Cell Infusion<br>Participants infused by vein with around 1 - 4 million/kg CD34+ selected cells. If the first infusion is not effective, an additional infusion may be given 4 - 6 weeks after the first infusion. | Biological: CD34 Positive Stem Cell Infusion<br>* Participants infused by vein with around 1 - 4 million/kg CD34+ selected cells.<br>Device: Miltenyi device<br>* Miltenyi device is used for CD34+ cell infusions) to patients who experience poor graft function after stem cell transplantation (SCT).<br>* Other names: CliniMACS device;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increased Graft Function after Stem Cell Transplantation (SCT) | Blood drawn for signs of graft versus host disease (GVHD). | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blood And Marrow Transplantation, Stem cell transplantation, SCT, Poor graft function, CD34+ cell infusion