ATCell™ Expanded Autologous, Adipose-Derived Mesenchymal Stem Cells

Status Active, not recruiting

Clinical Trial 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).

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04744051
Study type	Interventional
Source	American CryoStem Corporation
Contact
Status	Active, not recruiting
Phase	Phase 1
Start date	February 1, 2021
Completion date	January 31, 2024

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See also
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Recruiting	`NCT06015451` - Exercise in Postconcussion Symptoms and Posttraumatic Headache	N/A
Terminated	`NCT03339037` - Hyperbaric Oxygen Therapy Effect on Post Concussion Syndrome in Children	N/A
Completed	`NCT03895450` - Treating Persistent Post-concussion Symptoms With Exercise	N/A
Recruiting	`NCT02089594` - Hyperbaric Oxygen Treatment to Treat Mild Traumatic Brain Injury (mTBI)/Persistent Post-Concussion Syndrome (PPCS)	Phase 3
Active, not recruiting	`NCT04568369` - Treatment of Post-concussion Syndrome With TMS: Using FNIRS as a Biomarker of Response	N/A
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms