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
Overview
- Phase
- Phase 1
- Intervention
- PSC-01
- Conditions
- Knee Osteoarthritis
- Sponsor
- Personalized Stem Cells, Inc.
- Enrollment
- 125
- Locations
- 7
- Primary Endpoint
- Incidence of Adverse Events
- Last Updated
- 5 years ago
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.
Investigators
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
- •Uncontrolled diabetes
- •Prescribed immunosuppressive therapy at the time of consent
Arms & Interventions
PSC-01
All study participants will receive intraarticular injection of the investigational biological product, PSC-01.
Intervention: PSC-01
Outcomes
Primary Outcomes
Incidence of Adverse Events
Time Frame: 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 Outcomes
- Changes in KOOS Measurement(3-4 months)