Phase 1/2a Study of ANPD001 in Parkinson Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

PHASE1

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-23

Study Completion Date

2030-04-30

Brief Summary

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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.

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Detailed Description

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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)

Conditions

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Parkinson Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Open label, dose escalation of bilateral injection of ANPD001 dopaminergic precursor cells to the putamen

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ANPD001

Group Type EXPERIMENTAL

ANPD001

Intervention Type BIOLOGICAL

Biologic: ANPD001 is an experimental product derived from the patient's own skin cells converted to induced pluripotent stem cells. The stem cells were differentiated into precursors for brain cells that produce dopamine.

Custom Device

Intervention Type DEVICE

A custom device to facilitate slow injection of small volumes of investigational drugs (including cell therapies), under MRI guidance

Interventions

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ANPD001

Biologic: ANPD001 is an experimental product derived from the patient's own skin cells converted to induced pluripotent stem cells. The stem cells were differentiated into precursors for brain cells that produce dopamine.

Intervention Type BIOLOGICAL

Custom Device

A custom device to facilitate slow injection of small volumes of investigational drugs (including cell therapies), under MRI guidance

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

50 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No