Stem Cell Based Therapeutics for Chronic Disease

Overview

About this study

The purpose of this study is to produce, using current Good Manufacturing Practices (cGMPs), a bank of 50 primary fibroblast cell lines from skin biopsies obtained by consenting donors who meet 21 CFR 1271 donor eligibility criteria, and to use fibroblasts in the cell bank generated in aim 1 to produce new induced pluripotent stem cell lines using Good Manufacturing Practices (cGMPs). These iPSC lines will then be screened to identify those with optimal characteristics for treatment purposes, as well as for the potential generation of transplantable tissues and therapeutics for chronic disease.

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:

Females, 18 to 35 years of age (pregnancy assessed by self-report).
Non-pregnant.

Exclusion Criteria:

Male.
Known pregnancy (by self-report.
Known genetic disorder (by self-report).
Cancer history (including any form of skin cancer).
Diabetes.
Failure to meet 21 CFR 1271 donor eligibility criteria based on responses to a donor eligibility questionnaire.
Positive infectious disease result on any test in the infectious disease screening panel (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, CMV Total Ab, West Nile Virus NAT).
Medical records review.
Physical exam.

Eligibility last updated 1/12/23. Questions regarding updates should be directed to the study team contact.

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 Dennis Wigle, M.D., Ph.D.	Open for enrollment	Contact information: CRM Biotrust MAYOCLINICBIOTRUST@mayo.edu

Mayo Clinic Location

Status

Contact

Rochester, Minn.

Mayo Clinic principal investigator

Dennis Wigle, M.D., Ph.D.

Open for enrollment

Contact information:

CRM Biotrust

MAYOCLINICBIOTRUST@mayo.edu

More information

Publications

Publications are currently not available

Clinical Trials