Adipose-derived Stromal Vascular Fraction Cells to Treat Parkinson — SVFP1  

Idiopathic Parkinson Disease Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Idiopathic Parkinson Disease
• Parkinson Disease
• Parkinson's Disease and Parkinsonism
• Parkinsonian Disorders

• NCT number: NCT05699161
• Study type: Interventional
• Source: National Autonomous University of Nicaragua
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: October 14, 2021
• Completion date: October 31, 2022