Knee Osteoarthritis
Conditions
Keywords
cellular therapy, stromal vascular fraction, SVF, KOOS, autologous, mesenchymal stem cell, MSC, knee, osteoarthritis, adipose-derived mesenchymal stem cells, Ad-MSC, intraarticular
Brief summary
The objective of this clinical study is to evaluate the safety of an intraarticular injection of an investigational biologic product (IBP), PSC-01, the patient's own adipose-derived stromal vascular fraction cells (SVF) extracted from a lipoaspirate sample, to treat the pain of osteoarthritis in a single knee. The secondary objective is to get initial data on efficacy of the PSC-01.
Interventions
DRUGPSC-01
PSC-01 is a form of autologous cellular therapy resulting from the enzymatic processing of lipoaspirate to yield adipose-derived stromal vascular fraction cells.
Sponsors
Personalized Stem Cells, Inc.
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
* If a woman of childbearing potential, the study participant must not be pregnant at the time of consent and must take contraceptive measures to prevent a pregnancy while actively participating in the study * The study participant may be of any gender or ethnic background. * Must experience knee pain at least weekly for at least 3 months. * Must have failed a minimum of 6 weeks of first line, conservative therapy * Demonstrated clinical and radiographic evidence of OA diagnosis * Grade 2, 3, or 4 Kellgren-Lawrence score in one knee. * Normal or within protocol approved limits of laboratory blood and urinalysis tests * Must be suitable for cellular therapy per the Investigator's opinion * Must be suitable for liposuction per the Investigator's opinion * Must possess the cognitive ability to understand the investigational nature of this clinical trial and voluntarily provide consent for study participation
Exclusion criteria
* Evidence of OA in the contralateral knee with a Kellgren-Lawrence score greater than 2 * If a woman of child-bearing potential, the study participant must not be pregnant or attempt to become pregnant while actively taking part in the study. * Steroid injection in either knee within 60 days of providing informed consent * The subject must not be diagnosed with any of the following diseases at the time of consent: * Osteonecrosis * Active autoimmune disease * Serious cardiac condition * Psychotic Diseases * Epilepsy * Uncontrolled diabetes * Prescribed immunosuppressive therapy at the time of consent * Evidence of cancer at the time of consent * History of alcohol or substance abuse * Regular smoker at the time of consent * Received experimental medication or participated in another clinical study within 60 days of providing informed consent * Concurrent diseases or circumstances that the Investigator judges to be a potential risk to patient health or a confounding variable in the assessment of study endpoints.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Adverse Events | 3-4 months | The primary outcome measure of this study is to evaluate the safety of the investigational biological product, PSC-01.Safety will be assessed as the number of treatment-related adverse events as assessed by CTCAE v5.0. Adverse events will be assessed by physical examination, patient-reported health status, clinical pathology evaluations (cbc, chemistry, and urinalysis), and post-procedure clinical observations through the 84-day study period with post-treatment follow-up at 6 and 12 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in KOOS Measurement | 3-4 months | The secondary outcome measure of this study is to obtain initial data on the efficacy of PSC-01 on treating knee osteoarthritis. The efficacy primary outcome will be assessed using the KOOS knee survey with the five relevant subcategories of pain, symptoms, average daily living, sport/recreation, and quality of life measured at baseline, day 42 and day 84. |
Countries
United States
Outcome results
None listed