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

• ClinicalTrials.gov Identifier: NCT04043819
• Recruitment Status: Unknown
• First Posted: August 2, 2019
• Last Update Posted: September 16, 2020
• Sponsor: Personalized Stem Cells, Inc.
• Information provided by (Responsible Party): Personalized Stem Cells, Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Knee Osteoarthritis	Drug: PSC-01	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 125 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: September 7, 2019
• Estimated Primary Completion Date: January 2021
• Estimated Study Completion Date: January 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

1. Changes in KOOS Measurement [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, California

San Diego Orthobiologics Medical Group

Carlsbad, California, United States, 92011

Grossmont Orthopedic Medical Group

La Mesa, California, United States, 91942

Synergy Orthopedic Specialists Medical Group

San Diego, California, United States, 92121

The Orthohealing Center

Santa Monica, California, United States, 90025

United States, Illinois

Cellular Orthopedics

Des Plaines, Illinois, United States, 60016

United States, New Jersey

New Jersey Regenerative Institute

Cedar Knolls, New Jersey, United States, 07927

United States, Oregon

RestorePDX

Beaverton, Oregon, United States, 97008

Sponsors and Collaborators

Personalized Stem Cells, Inc.

More Information

• Responsible Party: Personalized Stem Cells, Inc.
• ClinicalTrials.gov Identifier: NCT04043819
• Other Study ID Numbers: PSC-CP-001
• First Posted: August 2, 2019
• Last Update Posted: September 16, 2020
• Last Verified: September 2020

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Personalized Stem Cells, Inc.:

SVF; knee; osteoarthritis; cellular therapy; stromal vascular fraction; KOOS; autologous; mesenchymal stem cell; MSC; adipose-derived mesenchymal stem cells; Ad-MSC; intraarticular

Additional relevant MeSH terms:

Osteoarthritis; Osteoarthritis, Knee; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases