Comprehensive database for studying stem cell transplants and cellular therapies
Protocol For A Research Database For Hematopoietic Stem Cell Transplantation, Other Cellular Therapies and Marrow Toxic Injuries
This study is creating a database to gather information on stem cell transplants and treatments to help improve recovery for patients and donors and make these therapies more accessible to everyone.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 99999999 (estimated) |
| Sex | All |
| Sponsor | Center for International Blood and Marrow Transplant Research Research network |
| Drugs / interventions | Radiation |
| Locations | 2 sites (Minneapolis, Minnesota and 1 other locations) |
| Trial ID | NCT01166009 on ClinicalTrials.gov |
What this trial studies
This research database aims to collect observational data to enhance the understanding of hematopoietic stem cell (HSC) transplantation and cellular therapies. It focuses on various aspects, including recipient recovery, the impact of genetics on outcomes, and improving access to these treatments for diverse patient groups. The database will also gather information on the recovery of donors after collection procedures and the effects of marrow toxic injuries. By analyzing this data, the study seeks to identify factors that contribute to successful transplant outcomes and potential areas for improvement.
Who should consider this trial
Good fit: Ideal candidates include recipients of HSC transplants from related or unrelated donors, as well as individuals treated for marrow toxic injuries at participating centers.
Not a fit: Patients who have not undergone stem cell transplantation or do not have marrow toxic injuries may not benefit from this study.
Why it matters
Potential benefit: If successful, this research could lead to improved recovery strategies and outcomes for patients undergoing stem cell transplants and cellular therapies.
How similar studies have performed: Other studies utilizing observational databases for stem cell transplantation have shown promise in improving patient outcomes, indicating that this approach is supported by prior success.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Minneapolis, Minnesota and 1 other locations
- Center for International Blood and Marrow Transplant Research — Minneapolis, Minnesota, United States (Recruiting)
- Medical College of Wisconsin — Milwaukee, Wisconsin, United States (Recruiting)
Study contacts
- Principal investigator: Patricia Steinert, PhD, MBA — Center for International Blood and Marrow Transplant Research
- Study coordinator: Leigh Anne Blackmon
- Email: databaseIRB@nmdp.org
- Phone: 763 406 8087
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.