Parkinsonian Brain Repair Using Human Stem Cells

• Status: Unknown status
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Celavie Bioscences, LLC
• Collaborator: Hospital Angeles del Pedregal

Criteria

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