Clinical trial NCT04043819: Evaluation of Safety and Exploratory Efficacy of an Autologous Adipose-derived Cell Therapy Product for Treatment of Single Knee Osteoarthritis
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Knee Osteoarthritis
Keywords: cellular therapy
stromal vascular fraction
SVF
KOOS
autologous
mesenchymal stem cell
MSC
knee
osteoarthritis
adipose-derived mesenchymal stem cells
Ad-MSC
intraarticular
Lead sponsor: Personalized Stem Cells, Inc.
Sponsor class: INDUSTRY
First posted: 2019-08-02
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of Adverse Events
timeFrame: 3-4 months
Secondary outcomes:
measure: Changes in KOOS Measurement
timeFrame: 3-4 months
Other outcomes:
Locations:
city: Carlsbad
country: United States
facility: San Diego Orthobiologics Medical Group
state: California
city: La Mesa
country: United States
facility: Grossmont Orthopedic Medical Group
state: California
city: San Diego
country: United States
facility: Synergy Orthopedic Specialists Medical Group
state: California
city: Santa Monica
country: United States
facility: The Orthohealing Center
state: California
city: Des Plaines
country: United States
facility: Cellular Orthopedics
state: Illinois
city: Cedar Knolls
country: United States
facility: New Jersey Regenerative Institute
state: New Jersey
city: Beaverton
country: United States
facility: RestorePDX
state: Oregon
Study officials:
References: