RecruitingNot ApplicableNCT01451502

Infusion of Cell Populations From Unlicensed Umbilical Cord Blood Units

Sponsor

Masonic Cancer Center, University of Minnesota

Enrollment

250 participants

Start Date

Oct 20, 2011

Study Type

INTERVENTIONAL

Conditions

Hematopoietic Malignancy Lymphatic Diseases

Summary

For the next 5-10 years or possibly longer, a high proportion of the Cord Blood Banks (CBB) inventory worldwide will be composed of unlicensed umbilical cord blood (UCB) units. While Food and Drug Administration (FDA)-licensed units will be prioritized, it will always be possible that an unlicensed unit will have known attributes, making it a better source of cells for the given indication. Because of the wide variety of current and potential indications as a source of cells for hematopoietic reconstitution or other form of cellular therapy, it is critical that the investigators have access to unlicensed UCB units.

Eligibility

Plain Language Summary

Simplified for easier understanding

This study allows patients who need a stem cell transplant using umbilical cord blood (UCB) to receive units that are not commercially licensed — when no licensed equivalent is available. It is a regulatory and safety protocol to ensure proper use of these unlicensed units. You may be eligible if: - You have a medical condition for which cord blood stem cell transplant is an approved treatment at your institution - You or your guardian provides written informed consent - The cord blood unit meets the required cell dose and HLA matching criteria - No equivalent licensed cord blood unit is available from an approved bank You may NOT be eligible if: - The exclusion criteria of the specific primary treatment protocol for your condition apply to you Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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