NCT02780895

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
8

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started May 2014

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

May 12, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 24, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

June 13, 2016

Status Verified

June 1, 2016

Enrollment Period

3.6 years

First QC Date

May 12, 2016

Last Update Submit

June 9, 2016

Conditions

Idiopathic Parkinson Disease

Keywords

Parkinson Diseasestereotactic surgeryhuman allogeneic fetal derived stem cells

Outcome Measures

Primary Outcomes (1)

  • Safety as Measured by the Number and Severity of Adverse Events

    three years

Secondary Outcomes (52)

  • FDOPA (L-3,4-dihydroxy-6-(18)F-fluorophenylalanine) uptake

    three years

  • Raclopride uptake

    three years

  • DTBZ ([18F]9-fluoropropyl-(+)-dihydrotetrabenazine) uptake

    three years

  • Barona Demographic Equation

    three years

  • North American Adult Reading Test (NAART)

    three years

  • +47 more secondary outcomes

Study Arms (1)

Single Arm Study

EXPERIMENTAL

stereotactic brain surgery of human stem cells (OK99)

Drug: Human Stem Cells

Interventions

Human Stem CellsDRUG

MRI-guided stereotactic intraputaminal cell implantation into PD patients was performed. For target locations, measurements were made using CT-scan images fused with previous MR images. Bilateral parasagittal incisions and corresponding 14 mm burr holes were made in preparation for cell suspension injections. To ensure complete cell suspension delivery, injections were carried out slowly for 2 min with reciprocal withdrawal of the delivery needle to avoid both damage to stem cells and brain tissue, as well as to avert reflux or bubble formation. After surgery, patients were kept in a conventional post-operative care unit for 1 h. The day following surgery, MR images were obtained to confirm correct placement of cell suspensions. All patients were discharged 24 h after surgery.

Also known as: OK99
Single Arm Study

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Angeles del Pedregal

Mexico City, Mexico

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

TNK1 protein, human

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Oleg Kopyov, MD, PhD

    Celavie Bioscences, LLC

    STUDY DIRECTOR

  • Ignacio Madrazo, MD, PhD

    Hospital Angeles del Pedregal

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2016

First Posted

May 24, 2016

Study Start

May 1, 2014

Primary Completion

December 1, 2017

Study Completion

December 1, 2018

Last Updated

June 13, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will share

Locations

ME(1)