Adipose-derived Stromal Vascular Fraction Cells to Treat Parkinson

NCT05699161 | Completed Phase 1 DMC

• 1 other identifier: Nica-Parkinson-2021
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (4)

• Incidence of treatment related adverse events

  Documentation of adverse events

  12-months follow-up post intervention.

• L-dopa medication

  Changes in L-dopa medication measured as levodopa-equivalent dose.

  Up to month 12 post intervention.

• Minimal clinically important differences (MCIDs)-1

  Estimation of MCIDs scores (0-199) based on the UPDRS scale: : MCID 4.3 points low, MCID 8.1 points medium, and MCID 17.1 points high.

  Up to 12-months post SVF treatment

• Minimal clinically important differences (MCIDs)-2

  Estimation of MCIDs scores (0-100) based on the PDQ-39 scale: : MCID 4.7 minimal, MCID 7.7 moderate, and MCID 10.1 significant.

  Up to 12-months post SVF treatment

Study Arms (1)

Single group assignment.

EXPERIMENTAL

Bilateral treatment. Subdermal plane injection of SVF cells into the submuscular aponeurotic fascia of the face.

Genetic: Adipose-derived stromal vascular fraction cells

Interventions

Adipose-derived stromal vascular fraction cells GENETIC

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.

Single group assignment.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with UK brain bank criteria for idiopathic Parkinson's disease for a period of not less than one year
• Age 18 - 80; male or female
• Stable PD medication for at least 30 days prior to study enrollment
• A MDS-UPDRS total score \> 20 and \< 50
• Ability to understand the study and sign consent forms
• Intent to comply with all postoperative appointments
• Social support to be able to comply with all follow-up visits

You may not qualify if:

• Previous neurological disease or previous brain trauma as a confounding factor
• Cardiovascular disease or any condition that prohibits general anesthesia
• Inability to understand and / or cooperate with investigators
• Subjects that have a history of injury, infection, or deformity of at or near the anatomical site for planned product injection which may increase their risk for infection, injury, or complication related to the product (e.g., prior injury to blood vessels, lymphatics, history of orbital injury/fracture).
• Rash or possible skin infection over surgical sites or face.
• Subjects that use any form of tobacco, including e-cigarettes, more than once a week over the past year.
• Current substance abuse (drugs or alcohol) within the 6 months prior to study enrollment

Sponsors & Collaborators

• Samuel Vilchez, PhD: lead
• Wake Forest University: collaborator
• Ministerio de Salud, Nicaragua: collaborator
• GID BIO, Inc.: collaborator
• National Autonomous University of Nicaragua: collaborator

Study Sites (1)

Hospital Escuela Oscar Danilo Rosales Arguello

León, León Department, Nicaragua

Location

Related Publications (7)

• Carstens M, Haq I, Martinez-Cerrato J, Dos-Anjos S, Bertram K, Correa D. Sustained clinical improvement of Parkinson's disease in two patients with facially-transplanted adipose-derived stromal vascular fraction cells. J Clin Neurosci. 2020 Nov;81:47-51. doi: 10.1016/j.jocn.2020.09.001. Epub 2020 Sep 25.

  PMID: 33222965 BACKGROUND

• Brown JC, Shang H, Li Y, Yang N, Patel N, Katz AJ. Isolation of Adipose-Derived Stromal Vascular Fraction Cells Using a Novel Point-of-Care Device: Cell Characterization and Review of the Literature. Tissue Eng Part C Methods. 2017 Mar;23(3):125-135. doi: 10.1089/ten.TEC.2016.0377.

  PMID: 28177263 BACKGROUND

• Nguyen A, Guo J, Banyard DA, Fadavi D, Toranto JD, Wirth GA, Paydar KZ, Evans GR, Widgerow AD. Stromal vascular fraction: A regenerative reality? Part 1: Current concepts and review of the literature. J Plast Reconstr Aesthet Surg. 2016 Feb;69(2):170-9. doi: 10.1016/j.bjps.2015.10.015. Epub 2015 Oct 31.

  PMID: 26565755 BACKGROUND

• Guo J, Nguyen A, Banyard DA, Fadavi D, Toranto JD, Wirth GA, Paydar KZ, Evans GR, Widgerow AD. Stromal vascular fraction: A regenerative reality? Part 2: Mechanisms of regenerative action. J Plast Reconstr Aesthet Surg. 2016 Feb;69(2):180-8. doi: 10.1016/j.bjps.2015.10.014. Epub 2015 Oct 24.

  PMID: 26546112 BACKGROUND

• Lindvall O. Treatment of Parkinson's disease using cell transplantation. Philos Trans R Soc Lond B Biol Sci. 2015 Oct 19;370(1680):20140370. doi: 10.1098/rstb.2014.0370.

  PMID: 26416681 BACKGROUND

• Shulman LM, Gruber-Baldini AL, Anderson KE, Fishman PS, Reich SG, Weiner WJ. The clinically important difference on the unified Parkinson's disease rating scale. Arch Neurol. 2010 Jan;67(1):64-70. doi: 10.1001/archneurol.2009.295.

  PMID: 20065131 BACKGROUND

• Horvath K, Aschermann Z, Kovacs M, Makkos A, Harmat M, Janszky J, Komoly S, Karadi K, Kovacs N. Changes in Quality of Life in Parkinson's Disease: How Large Must They Be to Be Relevant? Neuroepidemiology. 2017;48(1-2):1-8. doi: 10.1159/000455863. Epub 2017 Feb 4.

  PMID: 28161701 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease; Parkinsonian Disorders

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 7, 2022
• First Posted: January 26, 2023
• Study Start: October 14, 2021
• Primary Completion: October 31, 2022
• Study Completion: October 31, 2022
• Last Updated: January 26, 2023

Record last verified: 2023-01

Locations

NI (1)