This study is accepting new patients by invitation only

Phase 1/2a Study of ANPD001 in Parkinson Disease

a study on Parkinson's Disease

Summary

Eligibility
for people ages 50-70 (full criteria)
Location
at San Diego, California and other locations
Dates
study started
completion around

Description

Summary

This clinical trial is designed to test the safety and tolerability of injecting ANPD001 cells that will mature into dopamine-producing cells into the brain of participants with Parkinson Disease. All participants will have ANPD001 cells manufactured from their own previously collected cells.

Official Title

Phase 1/2a Dose Escalation Study of ANPD001 in Sporadic Parkinson Disease

Details

Participants will undergo a surgical implantation of cells that will mature into dopamine-producing neurons under general anesthesia into a part of the brain where dopamine production is decreased in patients with Parkinson Disease. The effect on Parkinson Disease symptoms, safety and tolerability, and cell survival are assessed for 5 years post-transplant (with MRI and PET imaging scans of the brain). Safety and tolerability are assessed annually for an additional 10 years via telephone call (total follow-up of 15 years)

Keywords

Parkinson Disease, Autologous, Induced Pluripotent Stem Cells, Cell Therapy, Dopamine, Regenerative Medicine, ANPD001, Custom Device

Eligibility

You can join if…

Open to people ages 50-70

  • Age 50-70 years of age at time of consent in the trial-ready cohort study ANPD001-01
  • Met all eligibility requirements for inclusion in the trial-ready cohort in clinical study ANPD001-01
  • Diagnosed with Parkinson Disease at least 4 years ago
  • Unequivocal motor response to Levodopa

You CAN'T join if...

  • Prior brain surgery that, in the opinion of the neurologist or neurosurgeon, contraindicates administration of ANPD001
  • History of intracranial therapy for PD, including deep brain stimulation (DBS), focused ultrasound (FUS), gene therapy or other biological therapy
  • History of cognitive impairment or dementia
  • History of clinically significant Dopa Dysregulation syndrome
  • History of epilepsy, stroke, multiple sclerosis, poorly controlled or progressive neurological disease (other than PD), or poorly controlled cardiovascular disease
  • Inability to temporarily stop anticoagulation or antiplatelet therapy for at least 2 weeks
  • History of malignancy (cerebral or systemic) within the prior 5 years, except treated cutaneous squamous or basal cell carcinomas
  • Contraindication to MRI and/or use of gadolinium
  • Weight > 300 lbs or Body Mass Index (BMI) > 35
  • Uncontrolled diabetes (HbA1c > 7.0%) or any other acute or chronic medical condition that would significantly increase the risks of a neurosurgical procedure
  • Pregnancy or lactation
  • Significant drug-induced dyskinesia (>2 for any body part on the Abnormal Involuntary Movement Scale [AIMS])
  • Male or female with reproductive capacity who is unwilling to use barrier contraception for 3 months post-administration of the investigational product
  • Unable to comply with the protocol procedures, including frequent and prolonged follow-up assessments
  • Any significant issue raised by the neurologist or neurosurgeon

Locations

  • University of California, San Diego
    San Diego California 92037 United States
  • Scripps Health
    La Jolla California 92037 United States

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
Aspen Neuroscience
ID
NCT06344026
Phase
Phase 1 Parkinson's Disease Research Study
Study Type
Interventional
Participants
Expecting 9 study participants
Last Updated