Health TrialsbyHealthPanel

A Study to Assess Safety and Efficacy of Surgical Implant of RNDP-001 in Patients With Idiopathic Parkinson's Disease

ConditionsIdiopathic Parkinson´s DiseaseParkinson's Disease
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age45-75
SponsorKenai Therapeutics

About this trial

This clinical trial is designed to test the safety and tolerability of the study intervention, RNDP-001, which will be implanted into the brain of study participants during a surgical procedure.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of idiopathic Parkinson's disease consistent with the Movement Disorders Society Clinical Criteria

Age 45 to 75

Medically stable to undergo a surgical procedure

Disqualifiers

Known Parkinson's disease gene mutation or variant

Previous infusion therapy or surgery for Parkinson's disease

History of allergic reaction or intolerance to an immunotherapeutic agent

Contraindication to MRI

Trial design

Design model

Sequential

Treatments tested in this trial

  • RNDP-001

    Biological/Vaccine

    Stem cells

  • Syringe Front-Loading Device

    Device

    Delivers the stem cells

Treatment groups

12 Participants
are divided into 3 treatment groups
Group A: First patient groupExperimental treatment 2 interventions
Group B: Second patient groupExperimental treatment 2 interventions
Group C: Third patient groupExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Safety and Tolerability

The incidence of adverse events (AEs), serious AEs, AEs of special interest, and patient withdrawals

Time frame
Baseline to 15 months post-transplant

Secondary outcomes

1

Changes from Baseline in Quality ON time measured by PD diary

Time frame
Baseline to 15 months post-transplant
2

Changes in Dopaminergic Function and Activity in the Brain

Changes in L-DOPA-positron emission tomography (PET)

Time frame
Baseline to 15 months post-transplant

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kenai Therapeutics

Lead sponsor

California Institute for Regenerative Medicine (CIRM)

Collaborator

Source ClinicalTrials.gov
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