Evaluation of Safety and Exploratory Efficacy of an Autologous Adipose-derived Cell Therapy Product for Treatment of Single Knee Osteoarthritis

Study Overview
=================
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.

Official Title
-----------------
Evaluation of Safety and Exploratory Efficacy of PSC-01, an Autologous Adipose-derived Stromal Vascular Fraction Cell Therapy Product for the Treatment of Knee Osteoarthritis

Conditions
-----------------
Knee Osteoarthritis

Intervention / Treatment
-----------------
* Drug: PSC-01


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PSC-01<br>All study participants will receive intraarticular injection of the investigational biological product, PSC-01. | Drug: PSC-01<br>* PSC-01 is a form of autologous cellular therapy resulting from the enzymatic processing of lipoaspirate to yield adipose-derived stromal vascular fraction cells.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Events | 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. | 3-4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in KOOS Measurement | 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. | 3-4 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cellular therapy, stromal vascular fraction, SVF, KOOS, autologous, mesenchymal stem cell, MSC, knee, osteoarthritis, adipose-derived mesenchymal stem cells, Ad-MSC, intraarticular