Osteo Arthritis Knee
Conditions
Keywords
Amniotic Fluid, Osteo Arthritis
Brief summary
This is a Phase I/II Randomized Double-Blinded Standard of Care (Corticosteroid) vs. Sterile Amniotic Fluid for Osteoarthritis
Detailed description
This study will look at blinded standard of care (SOC) steroid injection vs. amniotic fluid injection (pAF) to treat and reduce osteoarthritis (OA) inflammation and pain. The main objectives of this study are to establish the safety and tolerability of allogeneic intra-articular pAF injections. Secondary objectives include pain levels and functional outcome scoring in patients over a 12 month time frame.
Interventions
BIOLOGICALAmniotic Fluid Injection
Comparison of Standard of Care (Corticosteroid) injection vs. Sterile Processed Amniotic Fluid Injection for Knee Osteoarthritis
OTHERStandard of Care
Comparison of Standard of Care (Corticosteroid) injection vs. Sterile Processed Amniotic Fluid Injection for Knee Osteoarthritis
Sponsors
University of Utah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Half of the patients will be in the SOC treatment arm and half of the patients will be in the AF arm. The PI and patients will be blinded as to the arm in which they will be participating. Once the randomization number is obtained, unblinded research staff will prepare the appropriate study drug. The injections will be blinded to the research coordinator in charge of data entry, the treating physician and the patient.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patients who are between the ages of 18-70 years * A confirmed diagnosis of knee osteoarthritis based on clinical and radiographic findings consistent with Kellgren-Lawrence Stage 2-3 disease * Patients who have failed conservative treatment (e.g. steroid, activity modification, therapy, etc.) within 3 months * Unilateral or bilateral chronic knee joint pain \>4 months * Patients who are able to ambulate (i.e. not wheelchair bound) * Patient reported a typical pain of at least 4 out of 10 during the past week using VAS numeric pain scale (0-10) * Patients who are of childbearing potential must agree to use adequate contraception for 90 days after study drug injection
Exclusion criteria
* Subjects who have had a previous injection (i.e. steroid, platelet rich plasma, or other) within the last 3 months * A focal chondral defect, defined by x-ray evaluation * BMI \>40 as defined by NIH Clinical Guidelines Body Mass Index * Concurrent participation in another investigational trial involving systemic administration of agents (within the previous 30 days) or plans to participate in any other allogeneic stem cell therapy trial during the 12 month follow-up period * Clinical suspicion of infection at injection site * Any surgeries within 4 weeks, other than diagnostic surgery * Insulin or self-reported non-insulin dependent diabetic evident of HgA1c ≥8% among known diabetics * Unable to consent to an English Language Consent Form * Frank mechanical issues (i.e. locking of the knee) * Workman's Compensation cases * Rheumatoid arthritis * Patients with a known allergy to local anesthetics or components of the study drug (pAF or steroid injection) * Patients with vascular claudication or neurologic disorders affecting the index lower limb * Patients with inflammatory arthropathies or connective tissue disorders; or * Patients with known alcohol or drug abuse or dependence, recreational use of illicit drug or prescription medications, or have used medical marijuana within 7 days of study enrollment * Patients with history of active cancer/malignancy within 2 years of screening, apart from adequately treated basal cell or squamous cell carcinoma of the skin not associated with the target knee * Women who are nursing or pregnant * Patients of childbearing potential who are unwilling to use adequate contraception for 90 days after study drug injection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Repeat Allogeneic Intra-articular Injection Within 6 Months. | 6 months | Participants in both the SOC and pAF treatment arms may require and/or request rescue medication (i.e. SOC injection) at any time and will be given per PI discretion as part of standard of care. The clinicians will not know which study arm the study participant is in but will treat the participant with the SOC injection. This information will be documented and collected in the Electronic Medical Record (EMR), as well as the study's electronic data capture system. Participants will not be given any additional pAF injections throughout the study period. The participant will continue to be treated with SOC injections as needed. The outcome will be an indicator of whether or not a subject received a rescue medication within 6 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Knee Injury and Osteoarthritis Outcome Score (KOOS) | 6 months | Knee Injury and Osteoarthritis Outcome Score (KOOS) \[assessment of joint symptoms, pain, and function on a scale from 0 to 100\]. With higher scores representing better symptoms, pain and function. |
| Visual Analog Scale for Pain (VAS Pain) | 6 months | Pain was assessed using the Visual Analog Scale for pain (VAS), measured on a scale of 0 to 10. With 0 being no pain at all and 10 being the most pain possible. |
| Single Assessment Numerical Evaluation (SANE) | 6 months | Self-reported functional outcomes were evaluated throughout the study period using the Single Assessment Numerical Evaluation (SANE) \[scored as a percentage of normal for the affected joint on a scale from 0-100%\]. With higher values representing higher levels of function. |
| Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function Computer Adaptive Test (PF-CAT) | 6 months | Self-reported functional outcomes were evaluated using the PROMIS Physical Function Computer Adaptive Test \[self-report of capabilities related to activities of daily living scored from 0 to 100\]. With higher values representing higher levels of function. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDavid Petron, MD
University of Utah Orthopaedic Center
Participant flow
Recruitment details
Patients will be screened and consented at the University of Utah Orthopedic Center and all participating sub-investigator's clinics when they come for a standard of care physical exam. During this exam, the patient will be asked about their health and lifestyle, medical history, and current medications. As part of the SOC physical exam, the patient will also have standard of care pre-treatment x-rays, neurological assessment, and a diagnosis of mild to severe OA in the knee joint assessment.
Pre-assignment details
If the patient is found to be eligible for the study, research staff will approach the patient for informed consent. Patients with bi-lateral knee OA can participate but only one knee will receive the study treatment. The treating physician/principal investigator and the patient will discuss which knee should be treated with a study injection.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 60.1 years STANDARD_DEVIATION 10.72 |
| Body Mass Index | 27 kg/m² |
| Kellgren-Lawrence Score Grade 2 | 15 Participants |
| Kellgren-Lawrence Score Grade 3 | 34 Participants |
| Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain subscale | 56 Score on a scale |
| Knee Injury and Osteoarthritis Outcome Score (KOOS) Sport and Recreation Function subscale | 50 Score on a scale |
| Knee Injury and Osteoarthritis Outcome Score (KOOS) Symptoms subscale | 50 Score on a scale |
| Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function CAT | 44 Scores on a scale |
| Race/Ethnicity, Customized Race/Ethnicity Hispanic or Latino | 7 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Not Hispanic or Latino - Asian | 2 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Not Hispanic or Latino - White | 25 Participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 16 Participants |
| Single Assessment Numerical Evaluation (SANE) | 50 Percentage score |
| Visual Analog Scale (VAS) for pain | 6 Score on a scale |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 1 / 30 | 4 / 30 |
| serious Total, serious adverse events | 1 / 30 | 1 / 30 |
Outcome results
None listed