Infusion of unlicensed umbilical cord blood cells for treatment
Infusion of Cell Populations From Unlicensed Umbilical Cord Blood Units
This study is testing whether infusing unlicensed umbilical cord blood cells can help people with lymphatic diseases or blood cancers recover after their treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Sex | All |
| Sponsor | Masonic Cancer Center, University of Minnesota Academic / other |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT01451502 on ClinicalTrials.gov |
What this trial studies
This study involves the infusion of unlicensed umbilical cord blood (UCB) units into patients with lymphatic diseases or hematopoietic malignancies. Patients will receive pre-infusion hydration and medications to manage potential side effects. The study aims to explore the use of UCB as a source of hematopoietic stem cells for reconstitution after conditioning treatments, following specific protocols approved by the institutional review board at the University of Minnesota.
Who should consider this trial
Good fit: Ideal candidates include patients with specific diagnoses that require UCB for hematopoietic stem cell therapy and who meet the eligibility criteria set by the study.
Not a fit: Patients who do not have an unlicensed UCB unit that meets the required criteria or those without an appropriate diagnosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new source of stem cells for patients requiring hematopoietic reconstitution, potentially improving treatment outcomes.
How similar studies have performed: While the use of licensed UCB units has been well-studied, the infusion of unlicensed UCB units is a novel approach that has not been extensively tested in clinical settings.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: To be eligible for an unlicensed umbilical cord blood (UCB) unit, the subject must meet each of the eligibility criteria listed below: * Subjects with any diagnosis for which there is an institutional review board (IRB) approved treatment protocol that requires UCB as a source of hematopoietic stem cells for lympho-hematopoietic reconstitution after myeloablative or non myeloablative conditioning. * Subject (or parent/guardian) must provide written informed consent for the use of unlicensed UCB units with co-enrollment onto a University of Minnesota IRB-approved clinical trial that details the disease specific treatment plan that prescribes the use of UCB as source of cells * Subject has an unlicensed UCB unit that meets required cell dose and HLA matching criteria (as defined in the primary treatment protocol) that is considered negative for tested blood-borne pathogens and also lack an 'equivalent', licensed UCB unit from a University of Minnesota approved Cord Blood Bank Exclusion Criteria: * Exclusion criteria are specified in the treatment protocol according to indication.
Where this trial is running
Minneapolis, Minnesota
- Masonic Cancer Center, University of Minnesota — Minneapolis, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Alex Hoover, MD, MSc — Masonic Cancer Center, University of Minnesota
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.