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

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.

Study Overview

• Status: Unknown
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Drug: PSC-01

• Study Type: Interventional
• Enrollment (Anticipated): 125
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Carlsbad, California, United States, 92011
      • San Diego Orthobiologics Medical Group
    • La Mesa, California, United States, 91942
      • Grossmont Orthopedic Medical Group
    • San Diego, California, United States, 92121
      • Synergy Orthopedic Specialists Medical Group
    • Santa Monica, California, United States, 90025
      • The Orthohealing Center
  • Illinois
    • Des Plaines, Illinois, United States, 60016
      • Cellular Orthopedics
  • New Jersey
    • Cedar Knolls, New Jersey, United States, 07927
      • New Jersey Regenerative Institute
  • Oregon
    • Beaverton, Oregon, United States, 97008
      • RestorePDX

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: PSC-01; All study participants will receive intraarticular injection of the investigational biological product, PSC-01.	Drug: PSC-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.

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

Collaborators and Investigators

• Sponsor: Personalized Stem Cells, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 7, 2019
• Primary Completion (ANTICIPATED): January 1, 2021
• Study Completion (ANTICIPATED): January 1, 2021

Study Registration Dates

• First Submitted: July 23, 2019
• First Submitted That Met QC Criteria: July 31, 2019
• First Posted (ACTUAL): August 2, 2019

Study Record Updates

• Last Update Posted (ACTUAL): September 16, 2020
• Last Update Submitted That Met QC Criteria: September 14, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: osteoarthritis; knee; autologous; MSC; cellular therapy; mesenchymal stem cell; KOOS; stromal vascular fraction; adipose-derived mesenchymal stem cells; intraarticular; SVF; Ad-MSC
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: PSC-CP-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No