Long Term Follow-up of Patients With Parkinson's Disease Who Had Administered of A9-DPC in SB-PD-001 Study
NCT Number: NCT06477744
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Parkinson's Disease
Interventions: BIOLOGICAL: Allogenic embryonic stem cellderived A9 dopamine progenitor cell (A9-DPC)_Low Dose|BIOLOGICAL: Allogenic embryonic stem cellderived A9 dopamine progenitor cell (A9-DPC)_High Dose
Sponsor: S.Biomedics Co., Ltd.
Collaborators: Severance Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 12
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-09-14
Completion Date: 2029-06-29
Locations: Yonsei Universitiy Health System, Severance Hospital, Seoul, 03722, Korea, Republic of

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.

Primary Outcome Measures: Adverse Event of Special Interests (AESIs), Review occurrence of adverse event of special interests (AESIs), 5 years after IP administration
Secondary Outcome Measures: MDS-UPDRS Total Score (defined On/Off), Present descriptive statistics (number of subjects, average, standard deviation, median, minimum, maximum) by each dose group about changes in the MDS-UPDRS Total Scores, up to 96 Weeks (24 months) after IP administration compared to baseline (-Day 14 to -Day 4).

* Defined-on condition: condition that the most positive functional effect, as agreed by the subject and the tester, after treatment with drugs for controlling the symptoms of Parkinson's disease
* Defined-off condition: condition after 12 hours off drugs for controlling the symptoms of Parkinson's disease, -Day 14 to -Day 4, 5 years after IP administration|MDS-UPDRS part Ⅲ (defined On/Off), Present descriptive statistics (number of subjects, average, standard deviation, median, minimum, maximum) by each dose group about changes in the MDS-UPDRS part Ⅲ (defined On/Off) up to 96 Weeks (24 months) after IP administration compared to baseline (-Day 14 to -Day 4).

* Defined-on condition: condition that the most positive functional effect, as agreed by the subject and the tester, after treatment with drugs for controlling the symptoms of Parkinson's disease
* Defined-off condition: condition after 12 hours off drugs for controlling the symptoms of Parkinson's disease, -Day 14 to -Day 4, 5 years after IP administration|MDS-UPDRS Ⅳ score, Present descriptive statistics (number of subjects, average, standard deviation, median, minimum, maximum) by each dose group about changes in the MDS-UPDRS Ⅳ score up to 96 Weeks (24 months) after IP administration compared to baseline (-Day 14 to -Day 4).

* Defined-on condition: condition that the most positive functional effect, as agreed by the subject and the tester, after treatment with drugs for controlling the symptoms of Parkinson's disease
* Defined-off condition: condition after 12 hours off drugs for controlling the symptoms of Parkinson's disease, -Day 14 to -Day 4, 5 years after IP administration