Ignite Creation Date:
2024-05-06 @ 4:06 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04876326
Status:
UNKNOWN
Last Update Posted:
2021-05-06
First Post:
2021-04-25
Brief Title:
Potential Use of Autologous and Allogeneic Mesenchymal Stem Cells in Patients With Multiple System Atrophy
Sponsor:
Indonesia University
Organization:
Indonesia University
Study Overview
Official Title:
Potential Use of Autologous and Allogeneic Mesenchymal Stem Cells in Patients With Multiple System Atrophy
Status:
UNKNOWN
Status Verified Date:
2021-05
Last Known Status:
RECRUITING
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:
The prevalence of Multiple System Atrophy MSA is reported to be between 34 - 49 cases per 100000 population The estimated average incidence is 06 - 07 cases per 100000 people per year Many patients are not diagnosed properly during their lifetime because of the difficulty in differentiating MSA from other disorders Approximately 29 - 33 of patients with isolated late onset cerebellar ataxia and 8 - 10 of patients with parkinsonism will develop MSA
There are currently no therapies that can cure or stop the progression of the disease The current pharmacological therapy is only to relieve symptoms Mesenchymal stem cells MSC are considered an efficient source of cells for therapy because they can be safely harvested and transplanted to donors or patients have low immunogenicity and have broad therapeutic potential Results from preliminary preclinical and clinical trials indicate the potential of MSC-based treatment in meeting several key aspects of neurodegeneration Stem cell-based therapy for neurodegenerative diseases aims to stop clinical damage by regenerating and by providing local support for damaged tissue in addition after transplantation MSCs have been shown to be capable of penetrating the lesion area and thus have great potential use as a means of administering therapeutic agents
The subjects of this study were patients who experienced possible MSA based on the consensus clinical criteria for MSA There will be three treatment groups with a total sample of 5 subjects each
Group 1 will receives MSC-Adipose Autologous with doses 2x50 million cells intratechally
Group 2 will receives MSC-Umbilical Cord Allogeneic with doses 2x 50 million cells intratechally
Group 3 will receives MSC-Umbilical Cord Allogeneic with doses 2x50 million cells intratechally and 2x10cc secretome MSC from Adipose Intravenously
Clinical improvement will be evaluated using the UMSARS scale PET-Scans MRI DaTScan IGF-1 BDNF Sympathetic skin respons SSR EMG Composite Autonomic Severity Score CASS High definition-Optical coherence tomography HD-OCT ERG VEP Log MAR chart Ishihara test and side adverse effect on MSC
This study is divided into six timeframes Before an implantation First Month after second implantation Third month after secondary implantation Sixth month after second implantation Ninth month after second implantation and Twelve month after second implantation The differences between the test variables are then used as an indicator to assess clinical improvement within the subjects
There are currently no therapies that can cure or stop the progression of the disease The current pharmacological therapy is only to relieve symptoms Mesenchymal stem cells MSC are considered an efficient source of cells for therapy because they can be safely harvested and transplanted to donors or patients have low immunogenicity and have broad therapeutic potential Results from preliminary preclinical and clinical trials indicate the potential of MSC-based treatment in meeting several key aspects of neurodegeneration Stem cell-based therapy for neurodegenerative diseases aims to stop clinical damage by regenerating and by providing local support for damaged tissue in addition after transplantation MSCs have been shown to be capable of penetrating the lesion area and thus have great potential use as a means of administering therapeutic agents
The subjects of this study were patients who experienced possible MSA based on the consensus clinical criteria for MSA There will be three treatment groups with a total sample of 5 subjects each
Group 1 will receives MSC-Adipose Autologous with doses 2x50 million cells intratechally
Group 2 will receives MSC-Umbilical Cord Allogeneic with doses 2x 50 million cells intratechally
Group 3 will receives MSC-Umbilical Cord Allogeneic with doses 2x50 million cells intratechally and 2x10cc secretome MSC from Adipose Intravenously
Clinical improvement will be evaluated using the UMSARS scale PET-Scans MRI DaTScan IGF-1 BDNF Sympathetic skin respons SSR EMG Composite Autonomic Severity Score CASS High definition-Optical coherence tomography HD-OCT ERG VEP Log MAR chart Ishihara test and side adverse effect on MSC
This study is divided into six timeframes Before an implantation First Month after second implantation Third month after secondary implantation Sixth month after second implantation Ninth month after second implantation and Twelve month after second implantation The differences between the test variables are then used as an indicator to assess clinical improvement within the subjects
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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