MedTrace Logo

Parkinsonian Brain Repair Using Human Stem Cells

NCT02780895 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2016-06-13

No results posted yet for this study

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.

Conditions

  • Idiopathic Parkinson Disease

Interventions

DRUG

Human Stem Cells

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.

Sponsors & Collaborators

  • Hospital Angeles del Pedregal

    collaborator OTHER

  • Celavie Bioscences, LLC

    lead INDUSTRY

Principal Investigators

  • Oleg Kopyov, MD, PhD · Celavie Bioscences, LLC

  • Ignacio Madrazo, MD, PhD · Hospital Angeles del Pedregal

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2017-12-31
Completion
2018-12-31

Countries

  • Mexico

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02780895 on ClinicalTrials.gov