Evaluation of Safety and Exploratory Efficacy of an Autologous Adipose-derived Cell Therapy Product for Treatment of Single Knee Osteoarthritis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04043819|
Recruitment Status : Unknown
Verified September 2020 by Personalized Stem Cells, Inc..
Recruitment status was: Active, not recruiting
First Posted : August 2, 2019
Last Update Posted : September 16, 2020
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|Condition or disease||Intervention/treatment||Phase|
|Knee Osteoarthritis||Drug: PSC-01||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||125 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
All study participants will receive intraarticular injection of the investigational biological product, 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.
- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 80 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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:
- Active autoimmune disease
- Serious cardiac condition
- Psychotic Diseases
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04043819
|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|
|Des Plaines, Illinois, United States, 60016|
|United States, New Jersey|
|New Jersey Regenerative Institute|
|Cedar Knolls, New Jersey, United States, 07927|
|United States, Oregon|
|Beaverton, Oregon, United States, 97008|
|Responsible Party:||Personalized Stem Cells, Inc.|
|Other Study ID Numbers:||
|First Posted:||August 2, 2019 Key Record Dates|
|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|
stromal vascular fraction
mesenchymal stem cell
adipose-derived mesenchymal stem cells