Summary

Eligibility
for people ages 50-76 (full criteria)
Location
at Orange, California and other locations
Dates
study started
estimated completion

Description

Summary

This clinical trial is designed to test whether surgically injecting nerve cells that make dopamine into the brain of Parkinson's disease patients is safe, and to monitor for potential side effects.

Official Title

Phase 1 Study To Assess the Safety and Tolerability of Human Embryonic Stem Cell-Derived Midbrain Dopamine Neuron Cell Therapy (MSK-DA01) For Advanced Parkinson's Disease

Details

Subjects will undergo surgical transplantation of the dopamine-producing cells under general anesthesia into a part of the brain called the putamen. Subjects then take medicines to partially suppress their immune system (aimed to prevent the body from rejecting the cells) for 1 year. Safety, tolerability, evidence of cell survival (using MRI and PET scans of the brain), and effect on Parkinson's disease symptoms are assessed for 2 years post-transplant.

Keywords

Advanced Parkinson's Disease Parkinson Disease MSK-DA01 MSK-DA01 Cell Delivery Device

Eligibility

You can join if…

Open to people ages 50-76

  • Age 50-76 years old (Canada)
  • Age 60-76 years old (United States)
  • Diagnosis of Parkinson's Disease made between 5 to 15 years ago
  • Taking levodopa, but with complications of therapy such as wearing off and/or dyskinesia
  • Able to participate in all study visits and evaluations, including brain MRI and PET scan
  • Existence of a study partner who may act as potential surrogate over long term for ongoing consent

You CAN'T join if...

  • Diagnosis of primary mitochondrial disorder, epilepsy, stroke, multiple sclerosis or other neurodegenerative diseases such as Alzheimer's disease
  • Prior Deep Brain Stimulation , lesion therapy, or gene therapy for PD
  • Prior surgical or radiation therapy to the brain or spinal cord
  • Any medical condition resulting in high risk of immunosuppressive drugs, including any active infectious disease
  • Inability to temporarily stop anti-platelet agents or other anti-coagulant medications without serious risk
  • Previous or currently active malignant disease within the past 5 years, except basal cell carcinoma or in situ uterine cervical carcinoma that have been treated
  • Severe obesity (>350 lbs) or any condition that prevents use of PET/MRI
  • Pregnancy or breastfeeding
  • Contraindication to surgery or general anesthesia
  • In the opinion of the investigator, any other condition regarded as making subject unsuitable for trial

Locations

  • University of California Irvine accepting new patients
    Orange California 92868 United States
  • Toronto Western Hospital not yet accepting patients
    Toronto Ontario M5T 2S8 Canada

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
BlueRock Therapeutics
ID
NCT04802733
Phase
Phase 1
Study Type
Interventional
Last Updated