Autologous Stem Cell TransplantationNCT04920474
Protocol for a Research Sample Repository for Hematopoietic Cell Transplantation, Other Cellular Therapies and Marrow Toxic Injuries
An observational study of Autologous Stem Cell Transplantation and Allogeneic Stem Cell Transplantation, run by Center for International Blood and Marrow Transplant Research at 1 site in United States.
Trial summary
The primary purpose of the Research Sample Repository is to make blood samples available for research studies related to histocompatibility and hematopoietic cell transplantation (HCT) or other cellular therapy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Autologous Stem Cell Transplantation, Allogeneic Stem Cell Transplantation, Cellular Therapy
- How many people
- 99,999,999 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 1991to Jul 2030
- Phase
- Observational
- 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
Study population: Recipients and Donors that are involved with a stem cell transplantation process
Eligibility to participate in the Research Sample Repository Protocol:
Hematopoietic Cell (HC) or Other Cellular Therapy Donors
- Donors are eligible to participate in the Research Sample Repository if they have donated or are scheduled to donate HCs or cellular therapy products to an allogeneic recipient either by a marrow harvest or by apheresis. This includes adults with and without decision making capacity and children.
- All donors registered on the National Marrow Donor Program (NMDP) Registry, regardless of whether they have been requested to donate a product for a patient, are eligible to participate in the Research Sample Repository.
Cord Blood Units (CBUs)
- Testable material from CBUs (Specimens) infused at treatment centers covered under the C. W. Bill Young Transplantation Program are eligible for inclusion in the Research Sample Repository. Material may be submitted by participating treatment centers, centralized laboratories and Cord Blood Banks.
Hematopoietic Cell Transplantation or Other Cellular Therapy Recipients
- All U.S. recipients of allogeneic or autologous HC transplants or cellular therapies are eligible to participate in the Research Sample Repository. This includes adults with and without decision making capacity and children.
Patients with Marrow Toxic Injury
- Any patient who is treated for a marrow toxic injury at a center participating in the NMDP's Radiation Injury Treatment Network (RITN) is eligible to participate in the Research Sample Repository. This includes adults with and without decision-making capacity and children.
- Eligible patients may have received support care only, growth factor support, hematopoietic stem cell transplant or other appropriate medical treatment for marrow toxic injury
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ashley Spahn contact
United States1 site, 1 recruiting
- Recruiting
NMDP Biorepository
New Brighton, Minnesota, 55112
Liz Weideman, 651-745-5036, ewiedenm@nmdp.org
About this study
The primary purpose of the Research Sample Repository is to make blood samples available for research studies related to histocompatibility and hematopoietic cell transplantation (HCT) or other cellular therapy.
Representatives of participating centers and investigators or research groups may request access to research samples contained in the Research Sample Repository for the purpose of conducting research including:
- investigating molecular explanations for histocompatibility or clinical outcomes through analysis of genomic, epigenetic, or other biomolecular data
- evaluating the factors that affect transplant or cellular therapy outcome
- studying the distribution of HLA tissue types in different populations
- studying the success of transplantation, cellular therapies or supportive care in the management of marrow toxic injuries
- performing de-linked (anonymous) research
Read the detailed description
Research samples will be accepted from the following four categories:
- Hematopoietic Cell or other Cellular Therapy Donors
- Cord Blood Units
- Hematopoietic Cell Transplantation or other Cellular Therapy Recipients
- Patients with Marrow Toxic Injury
What is being measured
The primary outcome is the main question the study is designed to answer.
To make blood samples available for research studies related to histocompatibility and HCT or other cellular therapy
Measured: pre-HCT (recipient) or pre-donation (donor)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2021
- Study startJul 1991
- Primary completionJul 2030 (estimated)
- Study completionJul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autologous Stem Cell TransplantationStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 99,999,999 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Center for International Blood and Marrow Transplant Research
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Stephen Spellman, Principal investigator, NMDP Be The Match/CIBMTR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04920474
- Sponsor's protocol ID
- NMDP IRB-1991-0002
- Status last verified
- Mar 2023
- First submitted
- 3 Jun 2021
- Last updated
- 3 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol for a Research Sample Repository for Hematopoietic Cell Transplantation, Other Cellular Therapies and Marrow Toxic Injuries
- ClinicalTrials.gov ID
- NCT04920474
- Acronym / sponsor ID
- NMDP IRB-1991-0002
- Conditions
- Autologous Stem Cell Transplantation, Allogeneic Stem Cell Transplantation, Cellular Therapy, Marrow Toxic Injury
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 99,999,999 participants (estimated)
- Lead sponsor
- Center for International Blood and Marrow Transplant ResearchResearch network
- Study start
- Jul 1991 (actual)
- Primary completion
- Jul 2030 (estimated)
- Study completion
- Jul 2030 (estimated)
- First posted
- 9 Jun 2021 (actual)
- 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 primary purpose of the Research Sample Repository is to make blood samples available for research studies related to histocompatibility and hematopoietic cell transplantation (HCT) or other cellular therapy.
Representatives of participating centers and investigators or research groups may request access to research samples contained in the Research Sample Repository for the purpose of conducting research including:
- investigating molecular explanations for histocompatibility or clinical outcomes through analysis of genomic, epigenetic, or other biomolecular data
- evaluating the factors that affect transplant or cellular therapy outcome
- studying the distribution of HLA tissue types in different populations
- studying the success of transplantation, cellular therapies or supportive care in the management of marrow toxic injuries
- performing de-linked (anonymous) research
Detailed description
Research samples will be accepted from the following four categories:
- Hematopoietic Cell or other Cellular Therapy Donors
- Cord Blood Units
- Hematopoietic Cell Transplantation or other Cellular Therapy Recipients
- Patients with Marrow Toxic Injury
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Recipients and Donors that are involved with a stem cell transplantation process
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To make blood samples available for research studies related to histocompatibility and HCT or other cellular therapy
Time frame: pre-HCT (recipient) or pre-donation (donor)
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 3 May 2023.
- Research Sample Repository ProtocolLink 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.
Ashley Spahn contact
Stephen Spellman principal investigator
NMDP Be The Match/CIBMTR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autologous Stem Cell Transplantation and Allogeneic Stem Cell Transplantation, run by Center for International Blood and Marrow Transplant Research at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 May 2023. 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 Ashley Spahn (RepositoryIRB@NMDP.ORG), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To make blood samples available for research studies related to histocompatibility and HCT or other cellular therapy (time frame: pre-HCT (recipient) or pre-donation (donor)). 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 3 May 2023.