ATCell™ Expanded Autologous, Adipose-Derived Mesenchymal Stem Cells Deployed Via Intravenous Infusion

PHASE1UnknownINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

February 1, 2021

Primary Completion Date

September 30, 2023

Study Completion Date

January 31, 2024

Conditions
Post-Concussion Syndrome
Interventions
DRUG

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.

DRUG

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.

DRUG

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.

DRUG

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.

Trial Locations (1)

91942

BioSolutions Clinical Research Center, La Mesa

Sponsors
All Listed Sponsors
lead

American CryoStem Corporation

INDUSTRY

NCT04744051 - ATCell™ Expanded Autologous, Adipose-Derived Mesenchymal Stem Cells Deployed Via Intravenous Infusion | Biotech Hunter | Biotech Hunter