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

  • STATUS
    Recruiting
  • sponsor
    BlueRock
Updated on 13 September 2021
dopamine
dyskinesia

Summary

Dopamine neurons made from stem cells are injected into the brain under general anesthesia. Subjects then take medicines to partially suppress their immune system (aimed to prevent the body from rejecting the cells) for 1 year.

All subjects receive the treatment (i.e. there is no placebo group in this study).  Safety, tolerability, evidence of cell survival (using scans of the brain), and the effect on Parkinson's disease symptoms are assessed for 2 years post-transplant.

Description


Details
Condition Parkinson's disease
Clinical Study IdentifierTX278586
SponsorBlueRock
Last Modified on13 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 60-76 years old
Diagnosed with Parkinson’s Disease 5 to 15 years ago
Has complications of PD therapy such as wearing off and/or dyskinesia (slow uncontrolled writhing movements)
Able to participate in all study visits and evaluations including brain MRI and PET scans

Exclusion Criteria

Diagnosis of epilepsy, stroke, multiple sclerosis, Alzheimer’s disease or other serious brain diseases
Prior DBS, 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
Any other condition regarded as making subject unsuitable for trial. More detailed inclusion and exclusion criteria will be available from the study team
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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