Status:
UNKNOWN
Evaluation of Safety and Exploratory Efficacy of an Autologous Adipose-derived Cell Therapy Product for Treatment of Single Knee Osteoarthritis
Lead Sponsor:
Personalized Stem Cells, Inc.
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
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 f...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 7 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2021
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT04043819
Start Date
September 7 2019
End Date
January 1 2021
Last Update
September 16 2020
Active Locations (7)
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1
San Diego Orthobiologics Medical Group
Carlsbad, California, United States, 92011
2
Grossmont Orthopedic Medical Group
La Mesa, California, United States, 91942
3
Synergy Orthopedic Specialists Medical Group
San Diego, California, United States, 92121
4
The Orthohealing Center
Santa Monica, California, United States, 90025