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

Part of paid clinical trials in La Jolla, California.

Sponsor
University of California, San Diego
Study ID
NCT06482268
Phase
PHASE1
Status
Recruiting
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Conditions

  • PD - Parkinson's Disease

Eligibility Criteria

Sex
ALL
Age
40 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Human induced pluripotent stem cell-derived dopaminergic progenitors (CT1-DAP001) — COMBINATION_PRODUCT
    Investigational PET agents will be synthesized at UCSD and administered to subjects according to the local institutional guidelines. IND applications for these agents are linked with the IND application for the study product, CT1-DAP001. The IND applications for the PET radiopharmaceuticals contains the manufacturing method, specifications, quality testing, clinical usage, and safety and efficacy information for individual PET agents. Investigational Cell Injector Suniviion needle: The investigational instrument will be used to administer dopaminergic progenitors into the putamen. After aspirating cells, the instrument will be attached to a Leksell stereotactic frame to administer the cells into the brain.

Study Details

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

Key Dates

First listed
Jul 1, 2024
Start date
Jun 1, 2024
Status verified
Aug 2026
Primary completion
Dec 28, 2027
Completion
May 31, 2028

Study Design

Enrollment
7 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Other: Single-center, open-label, uncontrolled
    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

Primary Outcome Measure

Incidence And Severity Of Adverse Events [ Time Frame: 24 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San DiegoLa JollaCalifornia92037
Alpha Stem Cell Clinic
[email protected]
858-249-4020
Miguel Alvendia
[email protected]
858-249-4020
Joseph Ciacci, MD (PRINCIPAL_INVESTIGATOR)
Sharona Ben-Haim, MD (SUB_INVESTIGATOR)
Stephanie Lessig, MD (SUB_INVESTIGATOR)
Forseth Kiefer, MD (SUB_INVESTIGATOR)
Marsala Martin, MD (SUB_INVESTIGATOR)

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University of California, San Diego· La Jolla, CA

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