Implantation of Celavie human stem cells (OK99) is intended to address the underlying
pathology of the disease by replacing damaged/destroyed cells of the brain, and/or
stimulating the patient's brain to repair itself.
Drug: Human Stem Cells
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Full eligibility criteria for NCT02780895
Ages eligible for Study
18 Years to 75 Years
Genders eligible for Study
Accepts Healthy Volunteers
Diagnosis of idiopathic PD with tremor, rigidity or hypokinesia as major symptoms.
A two to twenty-five-year history of PD with significant medical management or difficulty in medical management.
A definite response to levodopa compounds with inadequately relieved of symptoms, or severe secondary effects of the drug.
Good general health.
A strong will or desire to have the procedure after being fully informed of its experimental nature.
History of repeated strokes with stepwise progression of parkinsonian features
History of repeated head injury
History of definite encephalitis
Oculogyric crises (unless drug-induced)
Neuroleptic treatment at onset of symptoms
Supranuclear gaze palsy
Presence of cerebral tumor or communicating hydrocephalus on CT scan
Sustained remission or negative response to an adequate dose of levodopa
Patients with parkinsonism other than Idiopathic PD
All locations for NCT02780895
Hospital Angeles del Pedregal
Mexico City, Mexico
View full eligibility
Tris trial is registered with FDA with number: NCT02780895. The sponsor of the trial is Celavie Bioscences, LLC and it is looking for 8 volunteers for the current phase.
Official trial title: Human OK99 Allogeneic Stem Cell Transplantation for Patients With Severe Parkinson's Disease
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