Title
Evaluation of Safety and Exploratory Efficacy of an Autologous Adipose-derived Cell Therapy Product for Treatment of Single Knee Osteoarthritis
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
Phase
Phase 1Lead Sponsor
Personalized Stem Cells, Inc.Study Type
InterventionalStatus
Unknown statusIndication/Condition
Knee OsteoarthritisIntervention/Treatment
PSC-01Study Participants
125The 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.
All study participants will receive intraarticular injection of the investigational biological product, PSC-01.
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.
