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Intravenous Plasma Treatment for Parkinson's Disease

NCT04202757 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2024-05-31

No results posted yet for this study

Summary

This study will do a preliminary evaluation of a possible treatment for mild-to-moderate Parkinson's disease. Patients will be treated with either transfusions of plasma from young donors. or with placebo transfusions. In the following several months, Parkinson's symptoms will be monitored and compared for the two groups.

Conditions

  • Idiopathic Parkinson Disease

Interventions

BIOLOGICAL

[21CFR640.30] Plasma from 18 - 25 year old volunteer donors

12.5 ml/kg intravenous Spectrum Plasma yFFP, per each of two infusions (25 ml/kg total), in combination with ongoing normal standard treatment.

OTHER

Saline

12.5 ml/kg intravenous 0.9% sodium chloride with 0.1% riboflavin , per each of two infusions (25 ml/kg total), in combination with ongoing normal standard treatment.

Sponsors & Collaborators

  • Carolina Longevity Institute

    collaborator UNKNOWN

  • The Neurology Center

    lead OTHER

Principal Investigators

  • Dian Ginsberg, M.D. · The Ginstitute of Functional Medicine

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-24
Primary Completion
2019-08-07
Completion
2019-08-08
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT04202757 on ClinicalTrials.gov