Evaluation of Safety and Exploratory Efficacy of an Autologous Adipose-derived Cell Therapy Product for Treatment of Single Knee Osteoarthritis
Status unconfirmed · Phase 1
Conditions studied: Knee Osteoarthritis
In brief
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.
Key facts
- Study ID
- NCT04043819
- Run by
- Personalized Stem Cells, Inc.
- People needed
- 125
- Starts
- 2019-09-07
- Expected to finish
- 2021-01-01
- Last updated by the study team
- 2020-09-16
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
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
- 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.
Where it is running
- 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
- New Jersey Regenerative Institute — Cedar Knolls, New Jersey, United States
- RestorePDX — Beaverton, Oregon, United States
Full record on ClinicalTrials.gov
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