Graft Versus Host Disease (GVHD)NCT01463475
University of Wisconsin hMSC Cell Bank: Bone Marrow Donor Protocol
A study testing Bone marrow aspirate in people with Graft Versus Host Disease (GVHD) and Acute Myocardial Infarction (AMI), run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The objective of this protocol is to use established standard criteria and methods for the collection of hMSC (human mesenchymal stromal cells) from healthy bone marrow donors. The hMSC collected from the donors will use to develop well-defined and reproducible cell banks. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Graft Versus Host Disease (GVHD), Acute Myocardial Infarction (AMI)
- What is being tested?
- Bone marrow aspirate
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Dec 2013
- Phase
- Interventional
- 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 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18 to 35 years
- Willingness to provide written informed consent
Who cannot join
- Presence of risk factors for or clinical evidence of Human immunodeficiency virus (type 1 and 2), Hepatitis B, Hepatitis C, Human T-lymphotrophic virus (type I and II), Human transmissible spongiform encephalopathy (including Creutzfeldt-Jakob disease) treponema pallidum,
- Presence of communicable disease risk associated with xenotransplantation.
- Test positive for Human immunodeficiency virus (type 1 and 2), Hepatitis B, Hepatitis C, Human T-lymphotrophic virus (type I and II), cytomegalovirus (CVM), West Nile Virus, treponema pallidum.
- Use of investigational drug within 30 days or 5 half lives which ever is longer. Use of investigational implanted device.
- History of malignancy.
- Pregnancy
- In the opinion of the hematologist or the investigator, a condition that compromises the ability of the donor to safely provide BM donation.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin-Madison
Madison, Wisconsin, 53792
About this study
The objective of this protocol is to use established standard criteria and methods for the collection of hMSC (human mesenchymal stromal cells) from healthy bone marrow donors. The hMSC collected from the donors will use to develop well-defined and reproducible cell banks. Standard manufacturing procedures and quality control testing methods will be used to characterize and evaluate the final cell product. After the cell banks are created, these cell products will be used in future translational or clinical research.
Read the detailed description
Cell banks will be manufactured and cellular products used for future translational or clinical research.
- Being tested
- Bone marrow aspirate
- Keywords
- MSC, Allogeneic, Bone marrow cells, Healthy subject donors, Collection of MSC from bone marrow aspirate, Bronchiolitis obliterans syndrome (BOS)
- Medical subject headings
- Graft vs Host Disease, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone marrow aspirateProcedure or surgery
Also called bone marrow-derived MSC
A single bone marrow aspirate procedure is planned.
| Study group | Role | What they receive |
|---|---|---|
| Bone Marrow Aspirate | Other | A qualified enrolled donor will have an aspirate bone marrow draw. Receives: Procedure: Bone marrow aspirate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Culture and expand mesenchymal stromal cells (MSC)
Cell viability, proliferation profile, and expression characteristics will be evaluated.
Measured: Day 1- cells are counted within 24 hours of bone marrow aspirate collection
Secondary outcomes (1)
Characterization profile of MSC during and after expansion will be assessed
Cell surface expression profile will be obtained using Flow Cytometry. Additional characterization includes cell differentiation profile.
Measured: Examine the cell surface marker profile of MSC using standard flow cytometry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2011 (estimated)
- Study startSep 2011
- Primary completionDec 2013
- Study completionDec 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.
- More trials run by University of Wisconsin, MadisonThe 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Peiman Hematti, MD, Principal investigator, University of Wisconsin, MadisonJohn M Centanni, MS, Study director, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01463475
- Sponsor's protocol ID
- H-2010-0104
- Other IDs
- HHSN268201000010C
- Status last verified
- Dec 2014
- First submitted
- 30 Sep 2011
- Last updated
- 4 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- University of Wisconsin hMSC Cell Bank: Bone Marrow Donor Protocol
- ClinicalTrials.gov ID
- NCT01463475
- Acronym / sponsor ID
- H-2010-0104
- Keywords
- MSC, Allogeneic, Bone marrow cells, Healthy subject donors, Collection of MSC from bone marrow aspirate, Bronchiolitis obliterans syndrome (BOS)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Sep 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 2 Nov 2011 (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.
The objective of this protocol is to use established standard criteria and methods for the collection of hMSC (human mesenchymal stromal cells) from healthy bone marrow donors. The hMSC collected from the donors will use to develop well-defined and reproducible cell banks. Standard manufacturing procedures and quality control testing methods will be used to characterize and evaluate the final cell product. After the cell banks are created, these cell products will be used in future translational or clinical research.
Detailed description
Cell banks will be manufactured and cellular products used for future translational or clinical research.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bone Marrow Aspirate | Other | Procedure: Bone marrow aspirateA qualified enrolled donor will have an aspirate bone marrow draw. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age 18 to 35 years
- Willingness to provide written informed consent
Key exclusion criteria (7 listed)
- Presence of risk factors for or clinical evidence of Human immunodeficiency virus (type 1 and 2), Hepatitis B, Hepatitis C, Human T-lymphotrophic virus (type I and II), Human transmissible spongiform encephalopathy (including Creutzfeldt-Jakob disease) treponema pallidum,
- Presence of communicable disease risk associated with xenotransplantation.
- Test positive for Human immunodeficiency virus (type 1 and 2), Hepatitis B, Hepatitis C, Human T-lymphotrophic virus (type I and II), cytomegalovirus (CVM), West Nile Virus, treponema pallidum.
- Use of investigational drug within 30 days or 5 half lives which ever is longer. Use of investigational implanted device.
- History of malignancy.
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 |
|---|---|---|
| Bone marrow aspirateAlso: bone marrow-derived MSCA single bone marrow aspirate procedure is planned. | Procedure or surgery | Bone Marrow Aspirate |
Primary outcome
Culture and expand mesenchymal stromal cells (MSC)
Time frame: Day 1- cells are counted within 24 hours of bone marrow aspirate collection
Cell viability, proliferation profile, and expression characteristics will be evaluated.
1 secondary outcome
Characterization profile of MSC during and after expansion will be assessed
Time frame: Examine the cell surface marker profile of MSC using standard flow cytometry
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2014.
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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.
Peiman Hematti, MD principal investigator
University of Wisconsin, Madison
John M Centanni, MS study director
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bone marrow aspirate in people with Graft Versus Host Disease (GVHD) and Acute Myocardial Infarction (AMI), run by University of Wisconsin, Madison 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 2 inclusion and 7 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: finished, as of the sponsor's last update on 4 Dec 2014. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
Culture and expand mesenchymal stromal cells (MSC) (time frame: Day 1- cells are counted within 24 hours of bone marrow aspirate collection). 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 4 Dec 2014.