Autologous iPSC-Derived Dopamine Neuron Transplantation for Parkinson's Disease

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Penelope J. Hallett, Ph.D.
Study ID
NCT06422208
Phase
PHASE1
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
55 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Autologous midbrain dopamine neurons — BIOLOGICAL
    The autologous midbrain dopamine neurons are a experimental cryopreserved cell product derived from human autologous induced pluripotent stem cells. The autologous midbrain dopamine neurons will be surgically administered into the putamen, unilaterally, in a single surgical session.

Study Details

This research study is evaluating an investigational cell product called autologous induced pluripotent stem cell (iPSC)-derived dopamine neurons. This research study is a single-center Phase 1/2a clinical trial, which will test the safety of injecting the investigational cell product into the brain of subjects with Parkinson's disease.

Key Dates

Start date
Aug 7, 2024
Status verified
Sep 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
6 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Autologous midbrain dopamine neurons

Primary Outcome Measure

Safety: number and severity of adverse events and serious adverse events [ Time Frame: Baseline to 12 months post-transplant and baseline to 18 months post-transplant ]

Locations (1)

FacilityCityStateZIPSite coordinators
Brigham & Women's HospitalBostonMassachusetts02215-

Find similar trials in Boston, MA

By condition
Parkinson's disease
By specialty
NeurologyBrain disorders
By research site
Brigham & Women's Hospital· Boston, MA

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