Parkinsonian Brain Repair Using Human Stem Cells (NCT02780895) | Clinical Trial Compass
UnknownPhase 1
Parkinsonian Brain Repair Using Human Stem Cells
Mexico8 participantsStarted 2014-05
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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
* Cerebellar signs
* Babinski sign
* 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
What they're measuring
1
Safety as Measured by the Number and Severity of Adverse Events