A Phase I Study of Surgically Implanted MSK-DA01 Cells for Advanced Parkinson's Disease

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Full 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

Purpose

The purpose of this study is to assess the safety of special cells that are surgically implanted in the brain in people with advanced Parkinson’s disease. The treatment, MSK-DA01, consists of cells that were grown and developed into brain cells that produce dopamine, the brain chemical that is decreased in people with Parkinson’s disease. Researchers want to know if the signs and symptoms of Parkinson’s disease change in response to MSK-DA01 and to see how the treatment influences patients’ quality of life.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have advanced Parkinson’s disease that was diagnosed at least 5 years but no more than 15 years before entering the study.
  • Patients must have had prior treatment with levodopa and at least one additional therapy.
  • Patients may not be candidates for deep brain stimulation (DBS) or must have been counseled regarding DBS as a treatment option and chose to pursue stem cell therapy instead.
  • This study is for patients ages 60-76.For more information about this study and to inquire about eligibility, please contact Dr. Harini Sarva at 212-746-2584.

For more information about this study and to inquire about eligibility, please contact Dr. Harini Sarva at 212-746-2584.

Protocol

18-518

Phase

I

Investigator

Harini Sarva