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Study To Assess the Safety and Tolerability of Human Embryonic Stem Cell-Derived Midbrain Dopamine N

Claire Henchcliffe


A Study On:

  • Parkinson Disease

Status:

  • Open

Eligibility

Inclusion Criteria:
- 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
** Note: There are additional inclusion criteria. The study center will determine if you meet all of the criteria.

Exclusion Criteria:
- 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
** Note: There are additional exclusion criteria. The study center will determine if you meet all of the criteria.

Interested in joining this trial?

Official Title

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.

Get in touch with our study team