Blood And Marrow TransplantationNCT02438904
Compassionate Access of the Miltenyi Device for CD34+ Cell Selection
A study testing CD34 Positive Stem Cell Infusion and Miltenyi device in people with Blood And Marrow Transplantation, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
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 more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Blood And Marrow Transplantation
- What is being tested?
- CD34 Positive Stem Cell Infusion and Miltenyi device
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 6 May 2015to 1 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 1) Patients who have poor or no graft function post stem cell transplantation.
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
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 detailed 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.
- Conditions
- Blood And Marrow Transplantation
- Being tested
- CD34 Positive Stem Cell Infusion, Miltenyi device
- Keywords
- Blood And Marrow Transplantation, Stem cell transplantation, SCT, Poor graft function, CD34+ cell infusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD34 Positive Stem Cell InfusionBiological
Participants infused by vein with around 1 - 4 million/kg CD34+ selected cells.
Miltenyi deviceDevice
Also called CliniMACS device
Miltenyi device is used for CD34+ cell infusions) to patients who experience poor graft function after stem cell transplantation (SCT).
| Study group | Role | What they receive |
|---|---|---|
| CD34 Positive Stem Cell Infusion | Experimental | 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. Receives: Biological: CD34 Positive Stem Cell Infusion; Device: Miltenyi device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increased Graft Function after Stem Cell Transplantation (SCT)
Blood drawn for signs of graft versus host disease (GVHD).
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2015 (estimated)
- Study start6 May 2015
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood And Marrow TransplantationStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elizabeth Shpall, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02438904
- Sponsor's protocol ID
- 2015-0295
- Other IDs
- NCI-2015-00979
- Status last verified
- May 2026
- First submitted
- 6 May 2015
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compassionate Access of the Miltenyi Device for CD34+ Cell Selection
- ClinicalTrials.gov ID
- NCT02438904
- Acronym / sponsor ID
- 2015-0295
- Conditions
- Blood And Marrow Transplantation
- Keywords
- Blood And Marrow Transplantation, Stem cell transplantation, SCT, Poor graft function, CD34+ cell infusion
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 6 May 2015 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 8 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CD34 Positive Stem Cell Infusion | Experimental | Biological: CD34 Positive Stem Cell Infusion, Device: Miltenyi deviceParticipants 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 1) Patients who have poor or no graft function post stem cell transplantation.
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CD34 Positive Stem Cell InfusionParticipants infused by vein with around 1 - 4 million/kg CD34+ selected cells. | Biological | CD34 Positive Stem Cell Infusion |
| Miltenyi deviceAlso: CliniMACS deviceMiltenyi device is used for CD34+ cell infusions) to patients who experience poor graft function after stem cell transplantation (SCT). | Device | CD34 Positive Stem Cell Infusion |
Primary outcome
Increased Graft Function after Stem Cell Transplantation (SCT)
Time frame: 4 weeks
Blood drawn for signs of graft versus host disease (GVHD).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- University of Texas MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elizabeth Shpall, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CD34 Positive Stem Cell Infusion and Miltenyi device in people with Blood And Marrow Transplantation, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elizabeth Shpall, MD (713-745-2161, eshpall@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increased Graft Function after Stem Cell Transplantation (SCT) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.