Status:
COMPLETED
Stem Cell and Growth Factor Injury and Arthritis Clinical Research Study
Lead Sponsor:
The Stone Research Foundation for Sports Medicine and Arthritis
Conditions:
Osteoarthritis, Knee
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The investigators believe that amniotic tissue allografts may be an effective modality to treat osteoarthritis (OA) of the knee. One important mechanism of action may be stimulation of the synovial ce...
Detailed Description
The investigators believe that amniotic tissue allografts may be an effective modality to treat osteoarthritis (OA) of the knee. One important mechanism of action may be stimulation of the synovial ce...
Eligibility Criteria
Inclusion
- Patients age 18 and over
- Previous diagnosis of knee OA,
- Kellgren-Lawrence grade of 2 - 4
- Minimum Visual Analogue Scale (VAS) pain score of 3 on a scale of 0 - 10 where 0 is no pain and 10 is the highest level of pain
- Can give written informed consent
Exclusion
- Receipt of HA, Platelet Rich Plasma (PRP) or amniotic cell injections in the previous 6 months
- Recent history of surgery to the same joint in the previous 3 months
- A clinical diagnosis of inflammatory arthritis made by history, examination or serology
- An active or latent infection of the affected knee joint or any other systemic infection currently under treatment or treated within the previous 3 months
- A history of chronic alcohol or drug abuse during the six months prior to the study
- Clinically documented acute or unstable concomitant disease, other than the condition to be treated in this study that might be a confounding reason for the presence of pathogens (i.e. renal, hepatic, cardiac, endocrine, hematologic, autoimmune, metabolic bone, crystal deposition, severe degenerative joint, neoplastic diseases)
- Systemic or intra-articular administration, within twenty days prior to the procedure, of any type of corticosteroids, antineoplastic, immune stimulating or immunosuppressive agents
- Participation in any other investigational drug or device trial during the 30 days prior to screening visit or who will receive such a drug or device during the course of this study
- Pregnant females
- Subject is unable to understand verbal and/or written English
Key Trial Info
Start Date :
January 4 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 10 2020
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT03408145
Start Date
January 4 2018
End Date
October 10 2020
Last Update
March 25 2021
Active Locations (1)
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1
Stone Research Foundation
San Francisco, California, United States, 94123