Compassionate Access of the Miltenyi Device for CD34+ Cell Selection
Blood And Marrow Transplantation
What this study involves
The registry says this study is recruiting. Individual locations may have different availability.
- Study type
- Interventional
- Phase
- Not applicable
- Age range
- Not specified - Not specified
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 200 Estimated
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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).
Read the full description
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.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
Inclusion Criteria:
1\) Patients who have poor or no graft function post stem cell transplantation.
Exclusion Criteria:
N/A
Understand screeningTreatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Not applicable
- Masking
- No masking
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.
Biological: CD34 Positive Stem Cell Infusion · Device: Miltenyi device
CD34 Positive Stem Cell Infusion BIOLOGICAL
Participants infused by vein with around 1 - 4 million/kg CD34+ selected cells.
Miltenyi device DEVICE
Miltenyi device is used for CD34+ cell infusions) to patients who experience poor graft function after stem cell transplantation (SCT).
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
Increased Graft Function after Stem Cell Transplantation (SCT)
Time frame: 4 weeks
Blood drawn for signs of graft versus host disease (GVHD).
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (1)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
1 locations
University of Texas MD Anderson Cancer CenterHouston, Texas, United StatesRecruiting
Study team and timeline
- Lead sponsor
- M.D. Anderson Cancer Center
- Study start
- May 6, 2015 Actual
- Primary completion
- May 1, 2027 Estimated
- Study completion
- May 1, 2027 Estimated
- First posted
- May 8, 2015 Estimated
- Last updated
- Nov 10, 2026 Actual
Official study contacts
Official study title
Compassionate Access of the Miltenyi Device for CD34+ Cell Selection
Ask Wellness Clinical Research
Your message goes to WCR, including when this study is run by another organization. WCR may offer general guidance but may not operate this trial, have access to its team or be able to enroll you.
Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 11, 2026 · Last registry update: Nov 10, 2026