Study of Generating and Banking Clinical-grade Stem Cells for Regenerative Medicine
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Jacksonville, Florida: 18-002920
Sponsor Protocol Number: 18-002920
About this study
The purpose of this study is to collect, convert and bank blood cells from healthy volunteers into stem cells (iPSCs) at a current good manufacturing practice (cGMP) facility within the Discovery and Innovation building on the Mayo FLorida campus. After comprehensive validation, we will bank those cGMP-iPSCs as a resource available to Mayo Clinic investigators and also to outside investigators as appropriate. Those bio-specimens could be unique resources to develop new protocols for production of clinical grade iPSC-derived cells, cell-derived products such as extracellular vesicles, and tissues to support Investigational New Drug (IND) and related clinical trials.
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 between the age of 18 and 70 years;
- Free from risk factors and clinical evidence of relevant communicable diseases;
- Free from communicable disease risks associated with xenotransplantation;
- Tests negative or non-reactive for relevant communicable disease agents;
- All eligible subjects regardless of their race, ethnicity, religion or gender.
Exclusion Criteria:
- Medical diagnosis of ZIKV in the past 6 months;
- Residence in, or travel to, an area with an increased risk for ZIKV transmission within the past 6 months;
- Sex within the past 6 months with a person who has either of the risk factors listed in items 1 or 2, above.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
More information
Publications
Publications are currently not available