NCT04744051

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

ATCell™ Expanded Autologous, Adipose-Derived Mesenchymal Stem Cells Deployed Via Intravenous Infusion for the Treatment of Post Concussion Syndrome (PCS) in Retired Military and Athletes

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: American CryoStem Corporation · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1 Clinical Safety Study intended to provide preliminary assessments of the safety, tolerability, and clinical alleviation of symptoms associated with Post Concussion Syndrome (PCS), also known as Chronic Concussive Syndrome (CCS).

Detailed description

The proposed study is a single-site, double-blinded, placebo-controlled study involving a single administration of either individual, autologous ATCell™ lines suspended in 5% dextrose lactated Ringer's solution or a vehicle (5% dextrose Lactated Ringer's solution) not containing cells. Each ATCell™ cell line will be created from cells grown from the stromal vascular fraction (SVF) of a participant's own adipose tissue collected by liposuction, and each treated participant will only receive their own cells. Within the treated group, 3 dosing levels will be explored: 50 million cells, 150 million cells, or 300 million cells, and a Placebo group which will receive 5% dextrose lactated Ringer's solution free of cells. Participant follow-ups will take place 1 day following the tissue harvest procedure and, 1 day, 1 week, 1 month, 3 months, and 6 months following ATCell™ treatment. Comprehensive participant's evaluations involving data collection will take place 1, 3, and 6 months following treatment. It has been proposed that in general, mild traumatic brain injuries (TBI) events need to be taken far more seriously, and that even mild TBI events can result in lasting negative consequences as evidenced by lower performances on neuropsychological assessments when compared with age-matched controls2. In fact, this condition may eventually lead to Alzheimer's Disease (AD) as well as Chronic Traumatic Encephalopathy (CTE), which, together may be termed the AD-like dementias3, further underscoring the need for effective clinical intervention. Currently, no effective treatments are available for this condition aside from treatment of the symptoms, although some more comprehensive treatments have been proposed.

Conditions

• Post-Concussion Syndrome

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-02-01
• Primary completion: 2023-09-30
• Completion: 2024-01-31
• First posted: 2021-02-08
• Last updated: 2023-06-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study