Graft-Versus-Host Disease(GVHD)NCT02026934
CliniMACS® CD34+ Reagent System for Expanded Access Use
A study testing CliniMACS CD34 Reagent System in people with Graft-Versus-Host Disease(GVHD) and Anemia Due to Disturbance of Proliferation and/or Differentiation of Hematopoietic Stem Cells, run by Joseph Antin at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Graft-Versus-Host Disease(GVHD), Anemia Due to Disturbance of Proliferation and/or Differentiation of Hematopoietic Stem Cells, Graft Failure
- What is being tested?
- CliniMACS CD34 Reagent System
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Symptomatic or uncontrolled cardiac failure or coronary artery disease.
- Karnofsky performance status < 60%.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
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.
Read the detailed description
- 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.
- Conditions
- Graft-Versus-Host Disease(GVHD), Anemia Due to Disturbance of Proliferation and/or Differentiation of Hematopoietic Stem Cells, Graft Failure, Delayed Graft Function
- Being tested
- CliniMACS CD34 Reagent System
- Keywords
- Graft-Versus-Host Disease(GVHD), Hematopoietic Stem Cell Transplantation., Graft failure, Graft exhaustion
- Medical subject headings
- Graft vs Host Disease, Delayed Graft Function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CliniMACS CD34 Reagent SystemDevice
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2014 (estimated)
- Study startMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graft-Versus-Host Disease(GVHD)Studies of the same condition, open and under way.
- 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Joseph Antin
- Sponsor type
- University, hospital or other
- Collaborators
- Miltenyi Biomedicine GmbH
- Responsible party
- Sponsor-investigator, Joseph Antin, Dana-Farber Cancer Institute
- Investigators
- Sarah Nikiforow, MD, PhD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02026934
- Sponsor's protocol ID
- 13-024
- Status last verified
- Nov 2016
- First submitted
- 2 Jan 2014
- Last updated
- 21 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CliniMACS® CD34+ Reagent System for Expanded Access Use
- ClinicalTrials.gov ID
- NCT02026934
- Acronym / sponsor ID
- 13-024
- Conditions
- Graft-Versus-Host Disease(GVHD), Anemia Due to Disturbance of Proliferation and/or Differentiation of Hematopoietic Stem Cells, Graft Failure, Delayed Graft Function
- Keywords
- Graft-Versus-Host Disease(GVHD), Hematopoietic Stem Cell Transplantation., Graft failure, Graft exhaustion
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Joseph AntinUniversity, hospital or other
- Collaborators
- Miltenyi Biomedicine GmbH
- Study start
- Mar 2013
- First posted
- 3 Jan 2014 (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.
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
- 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.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Symptomatic or uncontrolled cardiac failure or coronary artery disease.
- Karnofsky performance status < 60%.
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 |
|---|---|---|
| CliniMACS CD34 Reagent SystemFollowing 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. | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2016.
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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. This study is not recruiting at the moment.
Sarah Nikiforow, MD, PhD principal investigator
Dana-Farber Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CliniMACS CD34 Reagent System in people with Graft-Versus-Host Disease(GVHD) and Anemia Due to Disturbance of Proliferation and/or Differentiation of Hematopoietic Stem Cells, run by Joseph Antin 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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 21 Nov 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 21 Nov 2016; AzTrials last refreshed its copy on 29 Oct 2026.