Compassionate Access of the Miltenyi Device for CD34+ Cell Selection
NCT ID: NCT02438904
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
200 participants
INTERVENTIONAL
2015-05-06
2027-05-01
Brief Summary
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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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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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CD34 Positive Stem Cell Infusion
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.
CD34 Positive Stem Cell Infusion
Participants infused by vein with around 1 - 4 million/kg CD34+ selected cells.
Miltenyi device
Miltenyi device is used for CD34+ cell infusions) to patients who experience poor graft function after stem cell transplantation (SCT).
Interventions
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CD34 Positive Stem Cell Infusion
Participants infused by vein with around 1 - 4 million/kg CD34+ selected cells.
Miltenyi device
Miltenyi device is used for CD34+ cell infusions) to patients who experience poor graft function after stem cell transplantation (SCT).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
No
Sponsors
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M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Elizabeth Shpall, MD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Countries
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Central Contacts
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Provided Documents
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Document Type: Informed Consent Form
Related Links
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University of Texas MD Anderson Cancer Center
Other Identifiers
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NCI-2015-00979
Identifier Type: REGISTRY
Identifier Source: secondary_id
2015-0295
Identifier Type: -
Identifier Source: org_study_id