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

January 24, 2023 updated by: Samuel Vilchez, PhD

Treatment of Parkinson Disease With Transplantation of SVF Cells of Adipose Origin: Safety and Exploratory Efficacy Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Nicaragua
    • Leon
      • León, Leon, Nicaragua
        • Hospital Escuela Oscar Danilo Rosales Argüello

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single group assignment.

Bilateral treatment.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of treatment related adverse events
Time Frame: 12-months follow-up post intervention.
Documentation of adverse events
12-months follow-up post intervention.
L-dopa medication
Time Frame: Up to month 12 post intervention.
Changes in L-dopa medication measured as levodopa-equivalent dose.
Up to month 12 post intervention.
Minimal clinically important differences (MCIDs)-1
Time Frame: Up to 12-months post SVF treatment
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
Time Frame: Up to 12-months post SVF treatment
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samuel Vilchez, PhD

Collaborators

National Autonomous University of Nicaragua
Wake Forest University
GID BIO, Inc.
Ministerio de Salud, Nicaragua

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 14, 2021

Primary Completion (Actual)

October 31, 2022

Study Completion (Actual)

October 31, 2022

Study Registration Dates

First Submitted

December 7, 2022

First Submitted That Met QC Criteria

January 24, 2023

First Posted (Estimate)

January 26, 2023

Study Record Updates

Last Update Posted (Estimate)

January 26, 2023

Last Update Submitted That Met QC Criteria

January 24, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Nica-Parkinson-2021

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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