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 an experimental cryopreserved cell product derived from human autologous induced pluripotent stem cells. The autologous midbrain dopamine neurons are surgically administered into the putamen. Six participants received unilateral transplantation into one putamen. Six participants will receive bilateral transplantation into both putamina during 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

First listed
May 20, 2024
Start date
Aug 7, 2024
Status verified
Sep 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
12 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

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

Related Studies