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

Knee Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04043819
• Other study ID #: PSC-CP-001
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: September 7, 2019
• Est. completion date: January 2021

Study information

• Verified date: September 2020
• Source: Personalized Stem Cells, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 125
• Est. completion date: January 2021
• Est. primary completion date: January 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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.

Locations

Country	Name	City	State
United States	RestorePDX	Beaverton	Oregon
United States	San Diego Orthobiologics Medical Group	Carlsbad	California
United States	New Jersey Regenerative Institute	Cedar Knolls	New Jersey
United States	Cellular Orthopedics	Des Plaines	Illinois
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

Sponsors (1)

Lead Sponsor	Collaborator
Personalized Stem Cells, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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