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

Phase 1

• Conditions: Knee Osteoarthritis
• Interventions: Drug: PSC-01

• Registration Number: NCT04043819
• Lead Sponsor: Personalized Stem Cells, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-23
• Study First Submitted QC: 2019-07-31
• Study First Posted: 2019-08-02
• Study Start: 2019-09-07
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-14
• Last Update Posted: 2020-09-16
• Primary Completion: 2021-01
• Study Completion: 2021-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 125

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PSC-01	PSC-01	All study participants will receive intraarticular injection of the investigational biological product, PSC-01.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (7)

San Diego Orthobiologics Medical Group; 🇺🇸 Carlsbad, California, United States

Grossmont Orthopedic Medical Group; 🇺🇸 La Mesa, California, United States

Synergy Orthopedic Specialists Medical Group; 🇺🇸 San Diego, California, United States

The Orthohealing Center; 🇺🇸 Santa Monica, California, United States

Cellular Orthopedics; 🇺🇸 Des Plaines, Illinois, United States

RestorePDX; 🇺🇸 Beaverton, Oregon, United States

New Jersey Regenerative Institute; 🇺🇸 Cedar Knolls, New Jersey, United States