A randomized, double-blind, placebo-controlled trial comparing a single intra-articular injection of 2.0 mL AlloGen vs 2.0 mL sterile saline. Patients will be evaluated at baseline, 1 week, 6 weeks, 12 weeks, and 26 weeks.
This is a Phase 1, randomized, double-blind, placebo-controlled trial comparing a single intra-articular 2.0 mL injection of either AlloGen or sterile saline. Patients will be evaluated at baseline, 1 week, 6 weeks, 12 weeks, and 26 weeks. The patient will remain blinded to his or her treatment throughout the study duration. The investigator/assessor will also remain blinded throughout the treatment period. Only the individual(s) preparing the injection will not be blinded. Black tape over the injection syringe will mask the study treatment. Up to 30 adult patients with osteoarthritis of one knee that has failed to adequately respond to conservative non-pharmacologic therapy and simple analgesics, e.g., acetaminophen, will be enrolled at up to 5 sites in the US. The first 6 subjects will be staggered to evaluate any significant toxicity. Any adverse event data collected will be reviewed by the Data Safety Monitoring Board (DSMB) prior to treating the subsequent subject. Cumulative safety data from these 6 subjects will be reviewed by the DSMB.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Amniotic fluid
0.9% normal saline
Evaluate the safety of intra-articular (IA) administration of AlloGen Liquid in the target knee
The incidence of related Adverse Events (AEs), Serious Adverse Events (SAEs), and Unanticipated Adverse Events
Time frame: Baseline to 12 weeks
Evaluate preliminary efficacy of the injection by assessing pain subscale scores
Composite change from baseline in WOMAC-A (pain subscale) scores
Time frame: Baseline, 6, 12 and 26 weeks
Evaluate preliminary efficacy of the injection by assessing function subscale scores
Composite change from baseline in WOMAC-C (function subscale) score
Time frame: Baseline, 6, 12 and 26 weeks
Evaluate preliminary efficacy of the injection by assessing pain
Change from baseline in WOMAC-A scores
Time frame: Baseline, 6, 12 and 26 weeks
Evaluate preliminary efficacy of the injection by assessing function
Change from baseline in WOMAC-C score
Time frame: Baseline, 6, 12 and 26 weeks
Evaluate preliminary efficacy of the injection by Visual Analog Scale
Change from baseline in Visual Analog Scale (VAS)
Time frame: Baseline, 6, 12 and 26 weeks
Evaluate preliminary efficacy of the injection by assessing total WOMAC
Change from baseline in total WOMAC score
Time frame: Baseline, 6, 12 and 26 weeks
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Evaluate the safety of intra-articular (IA) administration of AlloGen Liquid in the target knee
Incidence of related Adverse Events (AEs), Serious Adverse Events (SAEs), and Unanticipated Adverse Events at 26 weeks
Time frame: 26 Weeks
Evaluate preliminary efficacy of the injection by assessing Patient-Reported Outcomes Measurement Information System (PROMIS)
Change from baseline in PROMIS pain interference and physical function scores
Time frame: Baseline, 6, 12 and 26 weeks
Evaluate preliminary efficacy of the injection by assessing total SF-12 score
Change from baseline in total SF-12 score
Time frame: Baseline, 6, 12 and 26 weeks
Evaluate preliminary efficacy of the injection by assessing total KOOS score
Change from baseline in total KOOS score
Time frame: Baseline, 6, 12 and 26 weeks