Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06608719
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-18
Brief Title:
Retrospective Study on the Safety and TherapeuticImprovement Effects of Intravenous Administration of SHED-CM for ALS SHED-CAH2023
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Retrospective Study on the Safety and TherapeuticImprovement Effects of Intravenous Administration of SHED-CM for ALS
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In this study we will retrospectively evaluate the safety and efficacy of administering SHED-CM for the treatment of ALS
Detailed Description:
Amyotrophic Lateral Sclerosis ALS is a progressive and irreversible neurodegenerative disease with limited treatment options Advances in regenerative medicine have opened new avenues for therapeutic interventions This retrospective cohort study evaluated the safety and efficacy of stem cells from human exfoliated deciduous teeth-conditioned media SHED-CM in 24 patients with ALS treated at a single facility between January 1 2022 and November 30 2023 Safety assessments included adverse events vital signs and laboratory test changes before and after administration whereas efficacy was measured using the ALS Functional Rating Scale-Revised ALSFRS-R grip strength and forced vital capacity while ALSFRS-R scores typically decline over time the progression rate in this cohort was slower suggesting a potential delay in disease progression Alternatively improvements in muscle strength and mobility were observed in some patients Although adverse events were reported in only 3 of cases no serious allergic reactions the treatment-induced changes in vital signs and laboratory results were not clinically significant The SHED-CM treatment appears to be a safe and potentially effective therapeutic option for patients with ALS Further research is needed to optimize the SHED-CM treatment however this study lays the groundwork for future exploration of regenerative therapies for ALS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None