Ignite Creation Date:
2025-12-24 @ 11:51 AM
Ignite Modification Date:
2026-01-04 @ 4:54 AM
Study NCT ID:
NCT05699161
Status:
COMPLETED
Last Update Posted:
2023-01-26
First Post:
2022-12-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adipose-derived Stromal Vascular Fraction Cells to Treat Parkinson
Sponsor:
Samuel Vilchez, PhD
Organization:
Study Overview
Official Title:
Treatment of Parkinson Disease With Transplantation of SVF Cells of Adipose Origin: Safety and Exploratory Efficacy Study
Status:
COMPLETED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SVFP1
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.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: