Ignite Creation Date:
2024-07-17 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06477744
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-06-12
Brief Title:
Long Term Follow-up of Patients With Parkinsons Disease Who Had Administered of A9-DPC in SB-PD-001 Study
Sponsor:
SBiomedics Co Ltd
Organization:
SBiomedics Co Ltd
Study Overview
Official Title:
Long Term Follow-up of Patients With Parkinsons Disease Who Had Administered of Allogenic Embryonic Stem Cell-derived A9 Dopamine Progenitor Cell A9-DPC in SB-PD-001 Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
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:
1 Long-term follow-up period Approximately 72 months from the date of approval by the Institutional Review Board IRB Study Period From the A9-DPC treatment date of the first subject in SB-PD-001 Study up to 5 years after the A9-DPC treatment of the last subject
2 Objectives This study aims to evaluate the long-term safety of A9-DPC by following up on the occurrence of adverse event of special interest AESI for 5 years from A9-DPC treatment date in subjects who have participated in SB-PD-001 Study and received A9-DPC In addition it will determine motor and non-motor symptoms over time following A9-DPC treatment as measured by MDS-UPDRS
3 Methods of the Long-term Follow-up This is a single center open-label 5-year long-term follow-up to evaluate the long-term safety in subjects receiving A9-DPC in SB-PD-001 Study
Among subjects who have received A9-DPC those who have provided voluntary written informed consent for participation of the long-term follow-up will be included The occurrence of AESIs is investigated for 5 years from A9-DPC treatment and MDS-UPDRS will be conducted for the efficacy assessment if the study can be conducted
To avoid any missing data about AESIs a phone or site visit will be performed at least once yearly from the start of the follow-up
2 Objectives This study aims to evaluate the long-term safety of A9-DPC by following up on the occurrence of adverse event of special interest AESI for 5 years from A9-DPC treatment date in subjects who have participated in SB-PD-001 Study and received A9-DPC In addition it will determine motor and non-motor symptoms over time following A9-DPC treatment as measured by MDS-UPDRS
3 Methods of the Long-term Follow-up This is a single center open-label 5-year long-term follow-up to evaluate the long-term safety in subjects receiving A9-DPC in SB-PD-001 Study
Among subjects who have received A9-DPC those who have provided voluntary written informed consent for participation of the long-term follow-up will be included The occurrence of AESIs is investigated for 5 years from A9-DPC treatment and MDS-UPDRS will be conducted for the efficacy assessment if the study can be conducted
To avoid any missing data about AESIs a phone or site visit will be performed at least once yearly from the start of the follow-up
Detailed Description:
1 Population of the Long-term Follow-up Subjects who have participated in SB-PD-001 Study and received A9-DPC about 12 subjects
2 Long-term Follow-up Period Approximately 72 months from the date of approval by the Institutional Review Board IRB
Study Period From the A9-DPC treatment date of the first subject in SB-PD-001 Study up to 5 years after the A9-DPC treatment of the last subject
Study Duration for Individual Subject 5 years from A9-DPC treatment date SB-PD-001 Study Phase 12a study of A9-DPC
3 Objectives and Endpoints of the Long-term Follow-up This study aims to evaluate the long-term safety of A9-DPC by following up on the occurrence of adverse event of special interest AESI for 5 years from A9-DPC treatment date in subjects who have participated in SB-PD-001 Study and received A9-DPC In addition it will determine motor and non-motor symptoms over time following A9-DPC treatment as measured by MDS-UPDRS
AESI is a minimum investigation item to be observed for long-term follow-up of stem cell treatment among the adverse events AEs that occur in the subjects receiving treatment In accordance with the Guideline for Long-term Follow-up of Advanced Biopharmaceuticals distributed by the Ministry of Food and Drug Safety in 2020 it is designated as below in this long-term follow-up AESIs refer to the serious adverse events SAEs in the guideline
Adverse Event of Special Interests AESIs
Early-onset AESIs up to 2 years after the study drug treatment
Infectious diseases
Complications related to the associated surgical procedures
Late-onset AESIs up to 5 years after the study drug treatment
Death
Generation of a neoplasm or malignant tumor in tissues or organs
Onset of an immune reaction including worsening of a previous autoimmune disease or new occurrence
Other delayed AESIs related to the treatment of embryonic stem cell-derived therapeutics
There is no delayed AESIs confirmed so far and when any additional AESIs are detected in the subsequent follow-up they will be added
4 Drug under Long-term Follow-up Allogenic embryonic stem cell-derived A9 dopamine progenitor cell A9-DPC
5 Inclusion Criteria
Persons who have participated in SB-PD-001 Study and received A9-DPC
Persons who have provided written informed consent for this long-term follow-up
6 Methods of the Long-term Follow-up This is a single center open-label 5-year long-term follow-up to evaluate the long-term safety in subjects receiving A9-DPC in SB-PD-001 Study
Among subjects who have received A9-DPC those who have provided voluntary written informed consent for participation of the long-term follow-up will be included The occurrence of AESIs is investigated for 5 years from A9-DPC treatment and MDS-UPDRS will be conducted for the efficacy assessment if the study can be conducted
To avoid any missing data about AESIs a phone or site visit will be performed at least once yearly from the start of the follow-up
7 Analysis Methods Adverse Event of Special Interests AESIs For AESIs the number of subjects affected incidence rate its exact 95 confidence interval CI and the number of events will be provided In addition the events will be coded using the Medical Dictionary For Regulatory Activities MedDRA with System Organ Class SOC and Preferred Term PT and the number of subjects affected incidence rate and the number of events will be provided
MDS-UPDRS Total Scoredefined OnOff part Ⅲ defined onoff and IV score For changes at each time point after the IP treatment from baseline descriptive statistics number of subjects mean standard deviation median minimum and maximum will be provided
2 Long-term Follow-up Period Approximately 72 months from the date of approval by the Institutional Review Board IRB
Study Period From the A9-DPC treatment date of the first subject in SB-PD-001 Study up to 5 years after the A9-DPC treatment of the last subject
Study Duration for Individual Subject 5 years from A9-DPC treatment date SB-PD-001 Study Phase 12a study of A9-DPC
3 Objectives and Endpoints of the Long-term Follow-up This study aims to evaluate the long-term safety of A9-DPC by following up on the occurrence of adverse event of special interest AESI for 5 years from A9-DPC treatment date in subjects who have participated in SB-PD-001 Study and received A9-DPC In addition it will determine motor and non-motor symptoms over time following A9-DPC treatment as measured by MDS-UPDRS
AESI is a minimum investigation item to be observed for long-term follow-up of stem cell treatment among the adverse events AEs that occur in the subjects receiving treatment In accordance with the Guideline for Long-term Follow-up of Advanced Biopharmaceuticals distributed by the Ministry of Food and Drug Safety in 2020 it is designated as below in this long-term follow-up AESIs refer to the serious adverse events SAEs in the guideline
Adverse Event of Special Interests AESIs
Early-onset AESIs up to 2 years after the study drug treatment
Infectious diseases
Complications related to the associated surgical procedures
Late-onset AESIs up to 5 years after the study drug treatment
Death
Generation of a neoplasm or malignant tumor in tissues or organs
Onset of an immune reaction including worsening of a previous autoimmune disease or new occurrence
Other delayed AESIs related to the treatment of embryonic stem cell-derived therapeutics
There is no delayed AESIs confirmed so far and when any additional AESIs are detected in the subsequent follow-up they will be added
4 Drug under Long-term Follow-up Allogenic embryonic stem cell-derived A9 dopamine progenitor cell A9-DPC
5 Inclusion Criteria
Persons who have participated in SB-PD-001 Study and received A9-DPC
Persons who have provided written informed consent for this long-term follow-up
6 Methods of the Long-term Follow-up This is a single center open-label 5-year long-term follow-up to evaluate the long-term safety in subjects receiving A9-DPC in SB-PD-001 Study
Among subjects who have received A9-DPC those who have provided voluntary written informed consent for participation of the long-term follow-up will be included The occurrence of AESIs is investigated for 5 years from A9-DPC treatment and MDS-UPDRS will be conducted for the efficacy assessment if the study can be conducted
To avoid any missing data about AESIs a phone or site visit will be performed at least once yearly from the start of the follow-up
7 Analysis Methods Adverse Event of Special Interests AESIs For AESIs the number of subjects affected incidence rate its exact 95 confidence interval CI and the number of events will be provided In addition the events will be coded using the Medical Dictionary For Regulatory Activities MedDRA with System Organ Class SOC and Preferred Term PT and the number of subjects affected incidence rate and the number of events will be provided
MDS-UPDRS Total Scoredefined OnOff part Ⅲ defined onoff and IV score For changes at each time point after the IP treatment from baseline descriptive statistics number of subjects mean standard deviation median minimum and maximum will be provided
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