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Adipose-derived Stromal Vascular Fraction Cells to Treat Parkinson (SVFP1)

Primary Purpose

Idiopathic Parkinson Disease, Parkinson's Disease and Parkinsonism

Status
Completed
Phase
Phase 1
Locations
Nicaragua
Study Type
Interventional
Intervention
Adipose-derived stromal vascular fraction cells
Sponsored by
Samuel Vilchez, PhD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Parkinson Disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

  • Hospital Escuela Oscar Danilo Rosales Arguello

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single group assignment.

Arm Description

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

Outcomes

Primary Outcome Measures

Incidence of treatment related adverse events
Documentation of adverse events
L-dopa medication
Changes in L-dopa medication measured as levodopa-equivalent dose.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
December 7, 2022
Last Updated
January 24, 2023
Sponsor
Samuel Vilchez, PhD
Collaborators
Wake Forest University, Ministerio de Salud, Nicaragua, GID BIO, Inc., National Autonomous University of Nicaragua
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1. Study Identification

Unique Protocol Identification Number
NCT05699161
Brief Title
Adipose-derived Stromal Vascular Fraction Cells to Treat Parkinson
Acronym
SVFP1
Official Title
Treatment of Parkinson Disease With Transplantation of SVF Cells of Adipose Origin: Safety and Exploratory Efficacy Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
October 14, 2021 (Actual)
Primary Completion Date
October 31, 2022 (Actual)
Study Completion Date
October 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Samuel Vilchez, PhD
Collaborators
Wake Forest University, Ministerio de Salud, Nicaragua, GID BIO, Inc., National Autonomous University of Nicaragua

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Pre-procedure/intervention evaluation Patients had a medical history, physical exam, and medication review. Neurological examination used two instruments: PDQ-39 and the MDS-UPDRS, the latter including videorecording of a standardized motor examination. Subjects also completed the general health questionnaire SF-36 and have blood drawn for subsequent biomarker analysis (immune markers L-1beta, IL-2, IL-6, IL-10, and TNF-alpha). Patients had pre-operative laboratory studies (hemogram, coagulation profile, electrolytes, BUN, creatinine, and urinalysis) and anesthesia evaluation carried out 48 hours prior to procedures. Surgical and biochemical technique The autologous fat tissue was harvested via liposuction by a plastic surgeon. The fat was washed and processed with collagenase for 60 minutes at a temperature of 39-41ºC, in an incubator and by constant shaking with a rotary shaker. The digested adipose tissue was then centrifuged for 14 minutes in 3 steps and the cell fraction (SVF) contained in the fat was removed with a syringe. The cell count was performed using a Luna Stem cell counter (Logos Bio). SVF was injected the same day as the liposuction and adipose processing. A standardized total dose of 30x10e6 SVF cells was administered [Carstens 2017]. Injections of SVF cells bilateral (into the subdermal plane along the submuscular aponeurotic fascia) 1 cc per site for a final dose of 0.3 million cells per site Post-surgical and management of complications Patients were observed for potentially adverse effects for 24 hours after the procedure. There were follow-up visits at seven days, 1-, 3-, 6- and 12 months postoperative and treatment period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Parkinson Disease, Parkinson's Disease and Parkinsonism

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single group assignment.
Arm Type
Experimental
Arm Description
Bilateral treatment. Subdermal plane injection of SVF cells into the submuscular aponeurotic fascia of the face.
Intervention Type
Genetic
Intervention Name(s)
Adipose-derived stromal vascular fraction cells
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of treatment related adverse events
Description
Documentation of adverse events
Time Frame
12-months follow-up post intervention.
Title
L-dopa medication
Description
Changes in L-dopa medication measured as levodopa-equivalent dose.
Time Frame
Up to month 12 post intervention.
Title
Minimal clinically important differences (MCIDs)-1
Description
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.
Time Frame
Up to 12-months post SVF treatment
Title
Minimal clinically important differences (MCIDs)-2
Description
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.
Time Frame
Up to 12-months post SVF treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Facility Information:
Facility Name
Hospital Escuela Oscar Danilo Rosales Arguello
City
León
State/Province
Leon
Country
Nicaragua

12. IPD Sharing Statement

Citations:
PubMed Identifier
33222965
Citation
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.
Results Reference
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PubMed Identifier
28177263
Citation
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.
Results Reference
background
PubMed Identifier
26565755
Citation
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.
Results Reference
background
PubMed Identifier
26546112
Citation
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.
Results Reference
background
PubMed Identifier
26416681
Citation
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.
Results Reference
background
PubMed Identifier
20065131
Citation
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.
Results Reference
background
PubMed Identifier
28161701
Citation
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.
Results Reference
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Adipose-derived Stromal Vascular Fraction Cells to Treat Parkinson

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