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Adipose-derived Stromal Vascular Fraction Cells to Treat Parkinson

NCT05699161 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2023-01-26

No results posted yet for this study

Summary

This is an interventional study to treat 10 patients with a diagnosis of Parkinson's disease with neurological assessment from the Oxford Parkinson's Disease Quotient-39 (PDQ-39) and Movement Disorders Society Universal Parkinson's Disease Rating Scale (MDS-UPDRS), with autologous adipose tissue-derived stromal vascular fraction (SVF) cells by subdermal plane injection into the submuscular aponeurotic fascia of the face.

This study assesses: 1) safety and 2) feasibility and 3) exploratory evidence of efficacy.

Conditions

  • Idiopathic Parkinson Disease
  • Parkinson's Disease and Parkinsonism

Interventions

GENETIC

Adipose-derived stromal vascular fraction cells

Published minimal clinically important differences (MCID) for PDQ-39; MDS-UPDRS; and levo-dopa equivalent dose and changes in the levels of blood proteins (L-1beta, IL-2, IL-6, IL-10, and TNF-alpha) in 10 patients after 12 months of treatment with SVF cells.

Sponsors & Collaborators

  • Wake Forest University

    collaborator OTHER

  • Ministerio de Salud, Nicaragua

    collaborator UNKNOWN

  • GID BIO, Inc.

    collaborator INDUSTRY

  • National Autonomous University of Nicaragua

    collaborator OTHER

  • Samuel Vilchez, PhD

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2021-10-14
Primary Completion
2022-10-31
Completion
2022-10-31

Countries

  • Nicaragua

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 NCT05699161 on ClinicalTrials.gov