RecruitingPhase 1NCT06482268

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

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)


Sponsor

University of California, San Diego

Enrollment

7 participants

Start Date

Jun 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 40 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a stem cell-based treatment for Parkinson's disease, where lab-grown dopamine-producing cells (made from iPS cells, a type of reprogrammed stem cell) are transplanted into the brain to replace the cells lost in Parkinson's. This is a Phase I/II safety and early efficacy trial. **You may be eligible if...** - You are 40–75 years old - You have had a confirmed Parkinson's disease diagnosis for at least 5 years - Your symptoms fluctuate between "ON" times (when medication is working) and "OFF" times (when it isn't) - Your medications are no longer providing adequate control - You respond to levodopa (a standard Parkinson's drug) by at least 30% - Your disease is at a moderate stage (Hoehn and Yahr stage 2 or higher when "off") **You may NOT be eligible if...** - You have severe uncontrolled movement complications (dyskinesia) - You have dementia or significant cognitive decline - You have had deep brain stimulation surgery - You have a history of brain cancer or significant brain abnormalities Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTHuman induced pluripotent stem cell-derived dopaminergic progenitors (CT1-DAP001)

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.


Locations(1)

University of California, San Diego

La Jolla, California, United States

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NCT06482268


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