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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PSC-01 | Experimental | All study participants will receive intraarticular injection of the investigational biological product, PSC-01. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PSC-01 | Drug | PSC-01 is a form of autologous cellular therapy resulting from the enzymatic processing of lipoaspirate to yield adipose-derived stromal vascular fraction cells. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
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:
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Diego Orthobiologics Medical Group | Carlsbad | California | 92011 | United States | ||
| Grossmont Orthopedic Medical Group |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38386505 | Derived | 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. |
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| 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 |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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