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 range

18 Years – 75 Years

Sex

ALL

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Safety as Measured by the Number and Severity of Adverse Events

Timeframe: three years

Trial details

NCT IDNCT02780895

SponsorCelavie Bioscences, LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-12

View on ClinicalTrials.gov More Idiopathic Parkinson Disease trials

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.