Idiopathic Parkinson Disease Clinical Trial
— SVFP1Official title:
Treatment of Parkinson Disease With Transplantation of SVF Cells of Adipose Origin: Safety and Exploratory Efficacy Study
Verified date | January 2023 |
Source | National Autonomous University of Nicaragua |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 10 |
Est. completion date | October 31, 2022 |
Est. primary completion date | October 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Nicaragua | Hospital Escuela Oscar Danilo Rosales Arguello | León | Leon |
Lead Sponsor | Collaborator |
---|---|
Samuel Vilchez, PhD | GID BIO, Inc., Ministerio de Salud, Nicaragua, National Autonomous University of Nicaragua, Wake Forest University |
Nicaragua,
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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of treatment related adverse events | Documentation of adverse events | 12-months follow-up post intervention. | |
Primary | L-dopa medication | Changes in L-dopa medication measured as levodopa-equivalent dose. | Up to month 12 post intervention. | |
Primary | 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 | |
Primary | 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 |
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