Study of AlloGen® Liquid Intra-articular Injection for Knee Osteoarthritis
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Osteoarthritis (Knee)
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Randomized, Placebo-Controlled, Double-BlindedMasking: Triple (Participant, Investigator, Outcomes Assessor)Masking Description: Subjects and investigators (including outcomes assessment) will be blinded to the treatment arm that is assigned.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 85 years
- Gender
- Both males and females
Description
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 thro...
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.
Tracking Information
- NCT #
- NCT04835389
- Collaborators
- Musculoskeletal Clinical Regulatory Advisers
- Investigators
- Principal Investigator: Brian Cole, MD Brian Cole MD