20
Participants
Start Date
February 1, 2021
Primary Completion Date
September 30, 2023
Study Completion Date
January 31, 2024
50 Adipose Derived Stem Cell Infusion
Each participant in this arm will receive a single dose of 50 million cultured adipose derived stem cells derived from their own adipose (fat) tissue via infusion therapy delivery over the course of one hour.
150 Adipose Derived Stem Cell Infusion
Each participant in this arm will receive a single dose of 150 million cultured adipose derived stem cells derived from their own adipose (fat) tissue via infusion therapy delivery over the course of one hour.
300 Adipose Derived Stem Cell Infusion
Each participant in this arm will receive a single dose of 300 million cultured adipose derived stem cells derived from their own adipose (fat) tissue via infusion therapy delivery over the course of one hour.
Placebo Infusion
Each participant in this arm will receive a single dose of placebo. Upon completion of the study each placebo participant will with be given the option to be treated with their cultured adipose derived stem cells derived from their own adipose (fat) tissue via infusion therapy delivery over the course of one hour. Dosage for the crossover will be determined by the PI following review of data collected from the other arms of the study.
BioSolutions Clinical Research Center, La Mesa
Lead Sponsor
American CryoStem Corporation
INDUSTRY