Idiopathic Parkinson Disease, Parkinson's Disease and Parkinsonism
Conditions
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.
Interventions
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.
Sponsors
Wake Forest University
Ministerio de Salud, Nicaragua
GID BIO, Inc.
National Autonomous University of Nicaragua
Samuel Vilchez, PhD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of treatment related adverse events | 12-months follow-up post intervention. | Documentation of adverse events |
| L-dopa medication | Up to month 12 post intervention. | Changes in L-dopa medication measured as levodopa-equivalent dose. |
| Minimal clinically important differences (MCIDs)-1 | 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. |
| Minimal clinically important differences (MCIDs)-2 | 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. |
Countries
Nicaragua
Outcome results
None listed