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New treatment option for PD - Parkinson's Disease
Official title Transplantation of Human iPS Cell-derived Dopaminergic Progenitors (CT1-DAP001) for Parkinson's Disease (Phase I/II)
ClinicalTrials.gov ID: NCT06482268
What this study is testing
What is Human induced pluripotent stem cell-derived dopaminergic progenitors (CT1-DAP001)?
Human induced pluripotent stem cell-derived dopaminergic progenitors (CT1-DAP001) is an investigational medicine, being studied as a potential treatment for pd - parkinson's disease.
Also referred to as Investigational imaging - FDOPA & FEPPA, Investigational device - Sunovion needle.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To evaluate the safety and efficacy of transplantation of human induced pluripotent stem cell-derived dopaminergic progenitors, CT1-DAP001, into the corpus striatum in patients with Parkinson's disease
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 75
You may be able to join if
- The subject has a diagnosis of PD (clinically established or clinically probable) in accordance with the MDS Clinical Diagnostic Criteria for...
- The subject has an inadequate response to drug treatments.
- The subject is ≥ 40 years and ≤ 75 years of age at the time of informed consent.
- The subject has had PD for at least 5 years.
- The subject has both ON and OFF (as demonstrated by the MDS-UPDRS Part III and a symptom diary).
You likely can't join if
- The subject has an abnormal brain MRI suggestive of brain pathology other than Parkinson's disease.
- Atypical parkinsonism (Parkinsonism-Plus syndrome, secondary parkinsonism, hereditary parkinsonism).
- The subject has clinical indication or diagnosis of abnormal immune function.
- The subject has been diagnosed with a major neurocognitive disorder such as dementia, or is high risk for this.
- The subject has bleeding tendency or abnormal coagulation function as evidenced by platelets \ 1.5x normal.
- The subject is HBs antigen-positive, or HBs antibody- or HBc antibody-positive with evidence of HBV-DNA.
See the full eligibility criteria
- The subject has a diagnosis of PD (clinically established or clinically probable) in accordance with the MDS Clinical Diagnostic Criteria for Parkinson's Disease (2015).
- The subject has an inadequate response to drug treatments.
- The subject is ≥ 40 years and ≤ 75 years of age at the time of informed consent.
- The subject has had PD for at least 5 years.
- The subject has both ON and OFF (as demonstrated by the MDS-UPDRS Part III and a symptom diary).
- The subject does not have a debilitating dyskinesia score greater than or equal to 3 on the MDS-UPDRS.
- The subject is in stage 2 or higher on the Hoehn and Yahr scale at OFF time.
- The subject is in stage 3 or lower on the Hoehn and Yahr scale at ON time.
- The subject has an L-dopa response of 30% or more without influence of antiparkinsonian drugs.
- The subject has the following organ functions as determined by laboratory tests at Screening visit:
- Neutrophil count ≥ 2,000/μL
- Platelet count ≥ 5.0 × 104/μL
- AST, ALT ≤ 3.0 × upper limit of normal
- Total bilirubin ≤ 1.5 × upper limit of normal
- eGFR ≥ 60 mL/min/1.73 m2 (As part of Creatinine testing, an estimated glomerular filtration rate (mL/min/1.73 m2)will be calculated based on the CKD-EPI 2021 equation)
- The subject is willing to avoid pregnancy using abstinence, highly effective means of birth control, surgical sterility, or menopause.
- The subject is willing to comply with the protocol-required assessments.
- The subject provides written informed consent to participate in the study. If the subject cannot sign due to physical constraints, verbal consent may be provided with signature of a Legally Authorized Representative.
- The subject has an abnormal brain MRI suggestive of brain pathology other than Parkinson's disease.
- Atypical parkinsonism (Parkinsonism-Plus syndrome, secondary parkinsonism, hereditary parkinsonism).
- The subject has clinical indication or diagnosis of abnormal immune function.
- The subject has been diagnosed with a major neurocognitive disorder such as dementia, or is high risk for this.
- The subject has bleeding tendency or abnormal coagulation function as evidenced by platelets \ 1.5x normal.
- The subject is HBs antigen-positive, or HBs antibody- or HBc antibody-positive with evidence of HBV-DNA.
- The subject is anti-HIV antibody positive.
- The subject is anti-HTLV-1 antibody-positive.
- The subject has active infection such as hepatitis C or syphilis (STS/TPHA).
- The subject has hypersensitivity or contraindication to tacrolimus, concomitant drugs (e.g., levodopa, carbidopa, MRI contrast), and/or their components.
- Contraindications to general anesthesia as evaluated by subject matter experts.
- The subject has a serious allergy to a component (e.g., gentamicin, component of bovine origin, or component of porcine origin) used in the preparation of the study product.
- The subject has any of the following conditions/diseases concurrently:
- Malignant neoplasm
- Epilepsy
- Psychiatric disease (e.g., uncontrolled anxiety or depression, bipolar disorder, schizophrenia)
- Diabetes mellitus with poorly controlled blood glucose (glycosylated hemoglobin \> 9.0%, or fasting plasma glucose (FPG) ≥ 200 mg/dL (11.1 mmol/L).
- Other serious concurrent diseases (e.g., cerebrovascular disorder, heart disease, chronic respiratory disease, inadequately controlled hypertension) as determined by the investigator.
- The subject has a history of any of the following:
- Prior malignancy \< 5 years prior to Screening. Patients who had prior malignancies within 5 years and in complete remission with expected survival of more than 5 years are not excluded
- Epilepsy
- Cerebral hemorrhage or stroke
- Psychiatric disease (e.g., uncontrolled anxiety or depression, bipolar disorder, schizophrenia)
- Congenital long QT syndrome
- Pallidotomy, thalamotomy, or Deep Brain Stimulation
- The subject is pregnant or lactating or does not agree to avoid pregnancy throughout the study.
- The subject has undergone transplantation of human iPSC-derived dopaminergic progenitors.
- The subject, in the opinion of the investigator or sub investigator, is not appropriate to conduct the study safely.
The study team makes the final eligibility decision.
Where it's taking place
- La Jolla, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include La Jolla, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.