A Phase I Open-Label Dose-Escalation Study to Evaluate the Safety, Tolerability, and Efficacy of Autologous MitoCell (Adipose-Derived Mesenchymal Stem Cells) Transplantation in Subjects With Idiopathic Parkinson's Disease
Trial ID: NCT05094011
Interventional - Phase 1 - Not yet recruiting
Primary Objective: To assess the safety profile of autologous MitoCell administered to subjects with idiopathic Parkinson's disease (PD)
Secondary Objective: To explore the efficacy and safety of MitoCell given as the recommended dose by stereotactic intrastriatal implantation
Conditions
Idiopathic Parkinson's Disease
Interventions
Aadipose-Derived Mesenchymal Stem Cells
Eligibility
Inclusion criteria
- Provision of signed and dated informed consent form
Aged 45 to 70 years old (inclusive) at Screening
Idiopathic Parkinson's disease patients who meet the diagnostic criteria of the "Movement Disorder Society Clinical Diagnostic Criteria for Parkinson's disease"
With at least 5 years since the diagnosis of Parkinson's disease
With responsiveness to levodopa or dopa agonist. This is defined as improvement between ''Off'' and ''On'' MDS-UPDRS by at least 33% of the Motor MDS-UPDRS
Idiopathic Parkinson's disease of Stage 3 ~ 4 of modified Hoehn & Yahr staging during ''ON'' time
Stable Parkinsonian medications for at least 2 months prior to the Screening Visit
MRI not showing gross atrophy or any brain pathology other than PD
Mini-Mental State Examination (MMSE) ≧ 24
With score of the Beck Depression Inventory (BDI-II) < 29 and Hamilton Rating Scale for Depression (HAM-D-17) < 25
Exclusion criteria
- Atypical or secondary Parkinsonism
With neurodegenerative disorders other than PD
Unable to receive MRI or PET scanning
With any concomitant disorder that would contraindicate coagulation, general anesthesia, or stereotactic neurosurgery
Received any other investigational agent within 4 weeks prior to Screening
History of intracranial surgeries or implantation of a device for Parkinson's disease 2 years prior to Screening
Major surgery within the previous 6 months at Screening
Significant cardiovascular disease, including:
New York Heart Association (NYHA) class III or IV congestive heart failure
Any diagnosis of autoimmune disease or immune compromised state and requiring systemic steroid or immunosuppressive treatment
Any other severe systemic disorder, including history of schizophrenia or other psychotic disorders, stroke, seizure, traumatic brain injury, or central nervous system infection, which judged by the investigator that entering the trial may be detrimental to the subject
Psychiatric, addictive or any other disorder that compromises ability to give a truly informed consent and perform all study assessments
Positive in any of the following regulatory authority-licensed screening tests:
HIV antigen/antibody combo test
Anti-HCV test
Hepatitis B surface antigen (HBsAg) test
Rapid plasma reagin (RPR) test
HIV-1 nucleic acid test (NAT)
HBV NAT
HCV NAT
Any of the following hematologic abnormalities:
Hemoglobin < 9.0 g/dL,
ANC < 1,500/μL
Platelets < 100,000/μL
Any of the following serum biochemistry abnormalities:
Total bilirubin > 1.5 × ULN
AST or ALT > 2.5 × ULN
r-GT > 2.5 × ULN
ALP > 2.5 × ULN
serum albumin < 3.0 g/dL
creatinine > 1.5 × ULN
Female subject who is lactating or has positive serum or urine pregnancy test at Screening Visit
Female subject with childbearing potential or male subject with female spouse/partner with childbearing potential who refuses to adopt at least two forms of birth control (at least one of which must be a barrier method) from Screening until Final/Early Termination Visit. Acceptable forms include:
Established use of oral, injected or implanted hormonal methods of contraception
Placement of an intrauterine device (IUD) or intrauterine system (IUS)
Barrier methods of contraception: condom, or occlusive cap (diaphragm or cervical/vault caps)
With any condition judged by the investigator that entering the trial may be detrimental to the subject