Ignite Creation Date:
2024-05-06 @ 3:45 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04744051
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-06-09
First Post:
2020-12-15
Brief Title:
ATCell Expanded Autologous Adipose-Derived Mesenchymal Stem Cells Deployed Via Intravenous Infusion
Sponsor:
American CryoStem Corporation
Organization:
American CryoStem Corporation
Study Overview
Official Title:
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:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 Ringers solution or a vehicle 5 dextrose Lactated Ringers solution not containing cells Each ATCell cell line will be created from cells grown from the stromal vascular fraction SVF of a participants 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 Ringers 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 participants 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 Alzheimers 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
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 Ringers 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 participants 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 Alzheimers 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| FDA File No 019089 | OTHER | US Food and Drug Administration | None |