The Establishment of an Allogeneic Cartilage Bank for the Center for Regenerative Medicine

Overview

About this study

The objectives of this study are to produce an allogeneic cartilage bank whereby cartilage tissue is obtained from consented donors who meet 21 CFR 1271 donor eligibility criteria, and to simluate clinical implantation of living donor osteochondral allografts banked from Aim 1, demonstrated to meet both viability and sterility requirements, in patients undergoing osteochondral transplantation in the Mayo clinical practice. Actual grafting using collected cartilage will not occur. This is a process validation study.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

Adults aged 18 - 60 years of age.
Scheduled for a total hip or total knee arthroplasty.
Must have acceptable radiographs demonstrating adequate healthy cartilage tissue for donation.

Exclusion Criteria:

Subjects < 18 and > 60 years of age.
Failure to meet 21 CFR 1271 donor eligibility criteria based on responses to a Tissue Donor History Questionnaire (administered during Visit 1).
Positive infectious disease result on any test in the infectious disease screening panel collected during Visit 1 or post-operatively (including HBsAg Screen, HBc Total Ab, HBV NAT, HCV NAT, HIV-1 NAT, HCV Ab Screen, HIV-1/-2, plus O Ab Screen, HTLV-I/-II Ab Screen, T. cruzi Total Ab, Syphilis Ab Screen, West Nile Virus NAT, ZIKA NAT ), and medical records review.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status	Contact
Rochester, Minn. Mayo Clinic principal investigator Daniel Saris, M.D., Ph.D.	Closed-enrolling by invitation What is this? (?) "Close" Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.	Contact information: CRM Biotrust MAYOCLINICBIOTRUST@mayo.edu

Mayo Clinic Location

Status

Contact

Rochester, Minn.

Mayo Clinic principal investigator

Daniel Saris, M.D., Ph.D.

Closed-enrolling by invitation

Contact information:

CRM Biotrust

MAYOCLINICBIOTRUST@mayo.edu

More information

Publications

Publications are currently not available

Clinical Trials