Autologous Stem Cell TransplantationNCT01166009
CIBMTR Research Database
An observational study of Autologous Stem Cell Transplantation and Allogeneic Stem Cell Transplantation, run by Center for International Blood and Marrow Transplant Research at 2 sites in United States.
Trial summary
The primary purpose of the Research Database is to have a comprehensive source of observational data that can be used to study HSC transplantation and cellular therapies. A secondary purpose of the Research Database is to have a comprehensive source of data to study marrow toxic injuries. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Autologous Stem Cell Transplantation, Allogeneic Stem Cell Transplantation, Solid Tumors
- How many people
- 99,999,999 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2002to Jul 2050
- 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 stem cell transplantation, other cellular therapies, and gene therapies.
Eligibility to Participate in the Research Database
Recipient Eligibility Criteria:
- Any recipient of an unrelated or related donor or autologous HSC transplant in a CIBMTR center is eligible to participate in the Research Database. This includes adults with and without decision making capacity, and children.
Individual with Marrow Toxic Injury Eligibility Criteria:
- Any individual who is treated for a marrow toxic injury at a center participating in the NMDP's Radiation Injury Transplant Network (RITN) is eligible to participate in the Research Database. This includes adults with and without decision making capacity, and children. Eligible individuals may have received supportive care only, growth factor support, HSC transplant or other appropriate medical treatment for marrow toxic injury. Treatments applied are at the discretion of the care facility, and are not determined by the NMDP or CIBMTR.
Unrelated Donor Eligibility Criteria:
- All donors registered on the NMDP Registry who have been requested to donate a product for a recipient are eligible to participate in the Research Database.
- All maternal cord blood donors are enrolled in the NMDP Cord Blood Bank Investigational New Drug (IND) protocol, and sign an informed consent document specific to that protocol. Data collected as part of the Cord Blood Bank protocol are included in the Research Database.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Brandan Butler, DatabaseIRB@nmdp.org
- Recruiting
Center for International Blood and Marrow Transplant Research
Minneapolis, Minnesota, 55413
Brandan Butler, DatabaseIRB@NMDP.org
About this study
Official title: Protocol For A Research Database For Hematopoietic Stem Cell Transplantation, Other Cellular Therapies and Marrow Toxic Injuries
The primary purpose of the Research Database is to have a comprehensive source of observational data that can be used to study HSC transplantation and cellular therapies.
A secondary purpose of the Research Database is to have a comprehensive source of data to study marrow toxic injuries.
Read more
Objectives:
To learn more about what makes stem cell transplants and cellular therapies work well such as:
- Determine how well recipients recover from their transplants or cellular therapy;
- Determine how recovery after a transplant or cellular therapy can be improved;
- Determine how a donor's or recipient's genetics impact recipient recovery after a transplant or cellular therapy;
- Determine how access to transplant or cellular therapy for different groups of patients can be improved;
- Determine how well donors recover from the collection procedures.
- Conditions
- Autologous Stem Cell Transplantation, Allogeneic Stem Cell Transplantation, Solid Tumors, Blood Cancers, CAR-T, Gene Therapy
- Keywords
- Data Collection, CIBMTR, NMDP, Stem Cell Transplantation, Gene Therapy, CAR-T
- Medical subject headings
- Hematologic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
A Comprehensive Source of Observational Data to assess Stem Cell Transplant
A primary outcome is to have a comprehensive source of stem cell transplant data that can be used to assess topics such as:
- Recipient Recover time
- How recovery after transplant and other cellular therapies can be improved
- Long term outcomes after transplantation and other cellular therapies
- How well donors recover from collection procedure
Measured: Anually - on average
Secondary outcomes (3)
A Comprehensive Source of Data for Marrow Toxic Injuries
In the event of a radiation exposure accident, the NMDP has a radiation injury treatment network, whose purpose is to collect data to understand the outcomes of patients treated under these circumstances. 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 Database.
Measured: anually- on average
Prospective Assessment of Allogeneic Hematopoietic Cell Transplantation in Patients with Medicare Coverage (17-CMS-SCD)
This protocol supports data collection for a sub study titled 17-CMS-SCD, an observational study to compare survival of patients 15 to 50 years of age with sickle cell disease who receive allogeneic transplantation compared to those receiving standard of care treatments.
- To provide a mechanism to Medicare Beneficiaries with sickle cell disease for claims coverage for allogenic hematopoietic cell transplant.
- To provide data requested by Medicare under its coverage with evidence development (CED) process to make payment on claims for HCT using the existing research observational database for the CIBMTR
Measured: annually - on average
Prospective Assessment of Allogeneic Hematopoietic Cell Transplantation in Patients with Medicare Coverage (10CMSMDS-1)
This protocol supports data collection for a sub-study titled 10-CMSMDS-1 with objective to prospectively examine outcomes of allogenic hematopoietic cell transplant in adults >= 65 years of age with myelodysplastic syndrome to determine whether their outcomes are similar to those in younger patients.
- To provide a mechanism for Medicare Beneficiaries with myelodysplastic syndrome for claims coverage for allogenic hematopoietic cell transplant
- To provide data requested by Medicare under its CED to make payment on claims for HCT using the existing research observational database of the CIBMTR"
Measured: annually - on average
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2010 (estimated)
- Study startJul 2002
- Primary completionJul 2050 (estimated)
- Study completionJul 2050 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Cohort
- 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
- Patricia Steinert, PhD, MBA, Principal investigator, Center for International Blood and Marrow Transplant Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01166009
- Sponsor's protocol ID
- NMDP IRB-2002-0063
- Status last verified
- Aug 2025
- First submitted
- 16 Jul 2010
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Atallah E, Logan B, Chen M, Cutler C, Deeg J, Jacoby M, Champlin R, Nishihori T, Confer D, Gajewski J, Farnia S, Greenberg P, Warlick E, Weisdorf D, Saber W, Horowitz MM, Rizzo JD. Comparison of Patient Age Groups in Transplantation for Myelodysplastic Syndrome: The Medicare Coverage With Evidence Development Study. JAMA Oncol. 2020 Apr 1;6(4):486-493. doi: 10.1001/jamaoncol.2019.5140.
PubMed 31830234
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol For A Research Database For Hematopoietic Stem Cell Transplantation, Other Cellular Therapies and Marrow Toxic Injuries
- ClinicalTrials.gov ID
- NCT01166009
- Acronym / sponsor ID
- NMDP IRB-2002-0063
- Conditions
- Autologous Stem Cell Transplantation, Allogeneic Stem Cell Transplantation, Solid Tumors, Blood Cancers, CAR-T, Gene Therapy
- Keywords
- Data Collection, CIBMTR, NMDP, Stem Cell Transplantation, Gene Therapy, CAR-T
- 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 2002
- Primary completion
- Jul 2050 (estimated)
- Study completion
- Jul 2050 (estimated)
- First posted
- 20 Jul 2010 (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 primary purpose of the Research Database is to have a comprehensive source of observational data that can be used to study HSC transplantation and cellular therapies.
A secondary purpose of the Research Database is to have a comprehensive source of data to study marrow toxic injuries.
Objectives:
To learn more about what makes stem cell transplants and cellular therapies work well such as:
- Determine how well recipients recover from their transplants or cellular therapy;
- Determine how recovery after a transplant or cellular therapy can be improved;
- Determine how a donor's or recipient's genetics impact recipient recovery after a transplant or cellular therapy;
- Determine how access to transplant or cellular therapy for different groups of patients can be improved;
- Determine how well donors recover from the collection procedures.
Study design
- Observational model
- Cohort
- 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 stem cell transplantation, other cellular therapies, and gene therapies.
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
A Comprehensive Source of Observational Data to assess Stem Cell Transplant
Time frame: Anually - on average
A primary outcome is to have a comprehensive source of stem cell transplant data that can be used to assess topics such as: * Recipient Recover time * How recovery after transplant and other cellular therapies can be improved * Long term outcomes after transplantation and other cellular therapies * How well donors recover from collection procedure
3 secondary outcomes
A Comprehensive Source of Data for Marrow Toxic Injuries
Time frame: anually- on average
Prospective Assessment of Allogeneic Hematopoietic Cell Transplantation in Patients with Medicare Coverage (17-CMS-SCD)
Time frame: annually - on average
Prospective Assessment of Allogeneic Hematopoietic Cell Transplantation in Patients with Medicare Coverage (10CMSMDS-1)
Time frame: annually - on average
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 12 Aug 2025.
- Derived from this study: PubMed 31830234Atallah E, Logan B, Chen M, Cutler C, Deeg J, Jacoby M, Champlin R, Nishihori T, Confer D, Gajewski J, Farnia S, Greenberg P, Warlick E, Weisdorf D, Saber W, Horowitz MM, Rizzo JD. Comparison of Patient Age Groups in Transplantation for Myelodysplastic Syndrome: The Medicare Coverage With Evidence Development Study. JAMA Oncol. 2020 Apr 1;6(4):486-493. doi: 10.1001/jamaoncol.2019.5140.
- Individual participant dataSharing planned: No
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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.
Patricia Steinert, PhD, MBA principal investigator
Center for International Blood and Marrow Transplant Research
2 sites 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 2 sites 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 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Leigh Anne Blackmon (763 406 8087, databaseIRB@nmdp.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A Comprehensive Source of Observational Data to assess Stem Cell Transplant (time frame: Anually - on average). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01166009, which also lists 1 linked publication.
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 12 Aug 2025.