Evaluation of Safety and Exploratory Efficacy of an Autologous Adipose-derived Cell Therapy Product for Treatment of Single Knee Osteoarthritis
1 other identifier
interventional
125
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 knee-osteoarthritis
Started Sep 2019
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 23, 2019
CompletedFirst Posted
Study publicly available on registry
August 2, 2019
CompletedStudy Start
First participant enrolled
September 7, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2021
CompletedSeptember 16, 2020
September 1, 2020
1.3 years
July 23, 2019
September 14, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Changes in KOOS Measurement
3-4 months
Study Arms (1)
PSC-01
EXPERIMENTALAll study participants will receive intraarticular injection of the investigational biological product, PSC-01.
Interventions
PSC-01 is a form of autologous cellular therapy resulting from the enzymatic processing of lipoaspirate to yield adipose-derived stromal vascular fraction cells.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
San Diego Orthobiologics Medical Group
Carlsbad, California, 92011, United States
Grossmont Orthopedic Medical Group
La Mesa, California, 91942, United States
Synergy Orthopedic Specialists Medical Group
San Diego, California, 92121, United States
The Orthohealing Center
Santa Monica, California, 90025, United States
Cellular Orthopedics
Des Plaines, Illinois, 60016, United States
New Jersey Regenerative Institute
Cedar Knolls, New Jersey, 07927, United States
RestorePDX
Beaverton, Oregon, 97008, United States
Related Publications (1)
Rogers CJ, Harman R, Sheinkop MB, Hanson P, Ambach MA, David T, Desai R, Sampson S, Aufierro D, Bowen J, Malanga G. Clinical Evaluation of Safety and Efficacy of a Central Current Good Manufacturing Practices Laboratory Produced Autologous Adipose-Derived Stromal Vascular Fraction Cell Therapy Product for the Treatment of Knee Osteoarthritis. Stem Cells Dev. 2024 Apr;33(7-8):168-176. doi: 10.1089/scd.2024.0008.
PMID: 38386505DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 23, 2019
First Posted
August 2, 2019
Study Start
September 7, 2019
Primary Completion
January 1, 2021
Study Completion
January 1, 2021
Last Updated
September 16, 2020
Record last verified: 2020-09