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Testing transplantation of lab-grown nerve-cell precursors

Researchers study the safety and effects of placing cells grown from reprogrammed human cells into the brain in people with Parkinson’s.

Testing a treatment or activity · Study reference: NCT06482268

Plain-language introduction written with AI from the registry; not independently checked by a clinician. Read the original details below ↓

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Start (reported actual date)
2024-06-01
Main measurements finished (planned)
2027-12-28
Study finished (planned)
2028-05

Planned dates can move. A study finishing does not tell us when a paper will be published.

No results summary has been confirmed in the registry records we imported. See connected papers below; we keep checking after recruitment ends.

Changes we have recorded
  • 2026-10-11 — recruiting

These are dates we observed a change, not necessarily the dates it happened.

Papers connected to this study

No connected paper has been found yet. The tracker checks the growing library for study identifiers and registry-linked publications.

Who can join?

Ages 40 years to 75 years · Does not accept healthy volunteers

These are starting points, not the full rules. The research team can tell you whether the study is right for your situation.

Read all the rules for taking part

Sex eligibility reported by registry: all

Inclusion Criteria: 1. 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). 2. The subject has an inadequate response to drug treatments. 3. The subject is ≥ 40 years and ≤ 75 years of age at the time of informed consent. 4. The subject has had PD for at least 5 years. 5. The subject has both ON and OFF (as demonstrated by the MDS-UPDRS Part III and a symptom diary). 6. The subject does not have a debilitating dyskinesia score greater than or equal to 3 on the MDS-UPDRS. 7. The subject is in stage 2 or higher on the Hoehn and Yahr scale at OFF time. 8. The subject is in stage 3 or lower on the Hoehn and Yahr scale at ON time. 9. The subject has an L-dopa response of 30% or more without influence of antiparkinsonian drugs. 10. The subject has the following organ functions as determined by laboratory tests at Screening visit: 1. Neutrophil count ≥ 2,000/μL 2. Platelet count ≥ 5.0 × 104/μL 3. AST, ALT ≤ 3.0 × upper limit of normal 4. Total bilirubin ≤ 1.5 × upper limit of normal 5. 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) 11. The subject is willing to avoid pregnancy using abstinence, highly effective means of birth control, surgical sterility, or menopause. 12. The subject is willing to comply with the protocol-required assessments. 13. 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. Exclusion Criteria: 1. The subject has an abnormal brain MRI suggestive of brain pathology other than Parkinson's disease. 2. Atypical parkinsonism (Parkinsonism-Plus syndrome, secondary parkinsonism, hereditary parkinsonism). 3. The subject has clinical indication or diagnosis of abnormal immune function. 4. The subject has been diagnosed with a major neurocognitive disorder such as dementia, or is high risk for this. 5. The subject has bleeding tendency or abnormal coagulation function as evidenced by platelets \<50 or PT/PTT \> 1.5x normal. 6. The subject is HBs antigen-positive, or HBs antibody- or HBc antibody-positive with evidence of HBV-DNA. 7. The subject is anti-HIV antibody positive. 8. The subject is anti-HTLV-1 antibody-positive. 9. The subject has active infection such as hepatitis C or syphilis (STS/TPHA). 10. The subject has hypersensitivity or contraindication to tacrolimus, concomitant drugs (e.g., levodopa, carbidopa, MRI contrast), and/or their components. 11. Contraindications to general anesthesia as evaluated by subject matter experts. 12. 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. 13. The subject has any of the following conditions/diseases concurrently: 1. Active malignancy 2. Epilepsy 3. Psychiatric disease (e.g., uncontrolled anxiety or depression, bipolar disorder, schizophrenia) 4. Diabetes mellitus with poorly controlled blood glucose (glycosylated hemoglobin \> 9.0%, or fasting plasma glucose (FPG) ≥ 200 mg/dL (11.1 mmol/L). 5. Other serious concurrent diseases (e.g., cerebrovascular disorder, heart disease, chronic respiratory disease, inadequately controlled hypertension) as determined by the investigator. 14. The subject has a history of any of the following: 1. 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 2. Epilepsy 3. Cerebral hemorrhage or stroke 4. Psychiatric disease (e.g., uncontrolled anxiety or depression, bipolar disorder, schizophrenia) 5. Congenital long QT syndrome 6. Pallidotomy, thalamotomy, or Deep Brain Stimulation 15. The subject is pregnant or lactating or does not agree to avoid pregnancy throughout the study. 16. The subject has undergone transplantation of human iPSC-derived dopaminergic progenitors. 17. The subject, in the opinion of the investigator or sub investigator, is not appropriate to conduct the study safely.
Full study name & original research details

Official study title

An Investigator-initiated Clinical Trial of Safety and Efficacy of Transplantation of Human Induced Pluripotent Stem Cell-derived Dopaminergic Progenitors (CT1-DAP001) for Parkinson's Disease (Phase I/II)

Short title used by the registry

Transplantation of Human iPS Cell-derived Dopaminergic Progenitors (CT1-DAP001) for Parkinson's Disease (Phase I/II)

Original description

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

Further description from the registry

Single-center, open-label, uncontrolled. The primary objective of this study is to evaluate the safety of CT1-DAP001 in subjects with Parkinson's disease by determining the incidence and severity of adverse events, especially graft expansion, after transplantation into the corpus striatum. Other objectives are to evaluate the efficacy of CT1-DAP001 through the assessment of Parkinson's disease symptoms and clinical severity or progression.

Conditions reported: PD - Parkinson's Disease

Registry records for this study

Records are joined using registration identifiers. Titles alone do not establish that two studies are the same.

Study type
Interventional
Interventions
Human induced pluripotent stem cell-derived dopaminergic progenitors (CT1-DAP001)
Phases
PHASE1
Sponsor
University of California, San Diego
Start date reported by registry
2024-06-01 (actual)

Registry updated: 2026-08-17 · Status last verified by the registry submitter: 2026-08

Registry records retrieved 2026-10-11 (UTC). Individual records may have older updates. Recruitment and eligibility must be confirmed with the study team.

Contact the research team

Public study contacts supplied to the registry. Ask whether recruitment is still open and what participation involves.

Alpha Stem Cell Clinic · (858) 249-4020 · AlphaStemCellClinic@health.ucsd.edu

Study locations

Site status can differ from overall study status. “Status not reported” means local availability needs confirmation. Remote participation and travel arrangements must be checked with the team.

University of California, San Diego

La Jolla, California, United States

Recruiting

Alpha Stem Cell Clinic · 858-249-4020 · AlphaStemCellClinic@health.ucsd.edu

Miguel Alvendia · 858-249-4020 · AlphaStemCellClinic@health.ucsd.edu

Joseph Ciacci, MD

Sharona Ben-Haim, MD

Stephanie Lessig, MD

Forseth Kiefer, MD

Marsala Martin, MD

The original descriptions and participation rules come from the registry. Participation is voluntary and does not guarantee benefit.