Study of Generating and Banking Clinical-grade Stem Cells for Regenerative Medicine

Overview

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 Mayo Clinic Human Cellular Therapy Laboratory (HCTL). 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.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Takahisa Kanekiyo, 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:

Prachi Kulahalli B.S.

Kulahalli.Prachi@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20445683

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