A Phase 1 Study Evaluating the Safety and Preliminary Efficacy of AlloGen® Liquid Intra-articular Injection for Knee Osteoarthritis
Overview
- Phase
- Phase 1
- Intervention
- AlloGen Liquid
- Conditions
- Osteoarthritis, Knee
- Sponsor
- VIVEX Biologics, Inc.
- Primary Endpoint
- Evaluate the safety of intra-articular (IA) administration of AlloGen Liquid in the target knee
- Status
- Withdrawn
- Last Updated
- 4 years ago
Overview
Brief Summary
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.
Detailed 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 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject has both clinical and radiographic findings consistent with osteoarthritis of the knee:
- •Subject has clinical findings including (but not limited to) tenderness to palpation, swelling/effusion, stiffness, chronic limited range of motion.
- •Subject has a diagnosis of knee osteoarthritis (OA) defined as Grade 2 to 3 using the Kellgren-Lawrence grading scale.
- •Failed conservative care over the past 3 months of at least 2 conservative treatments including oral pain medication \[analgesics, steroids and/or non-steroidal anti-inflammatory drugs (NSAIDs)\] and structured physical therapy or exercise program prescribed by physical therapist, chiropractor provider or physician specifically for the treatment of knee osteoarthritis.
- •Subject has a BMI less than 40 kg/m2
- •Subject is willing and able to provide informed consent and participate in all procedures and follow-up evaluations necessary to complete the study.
- •Subject must have a VAS pain score of 4 or greater on a 100-mm scale.
- •All subjects of reproductive age or capacity must use adequate contraception (abstinence, surgically sterilized, postmenopausal, or consistently use an effective contraception method) during the study.
- •Subject agrees not to take additional knee symptom-modifying drugs (e.g., glucosamine, collagen, hyaluronic acid) during the study without reporting the use to the study team.
Exclusion Criteria
- •Subject has a diagnosis of knee osteoarthritis (OA) defined as Grade 4 on the Kellgren-Lawrence grading scale.
- •Subject has active infection at the injection site.
- •Subject has symptomatic OA of the contralateral knee or of either hip (VAS≥40) that is not responsive to acetaminophen (Tylenol®) and/or Non-Steroidal Anti-Inflammatory Drugs (NSAIDs, e.g. Ibuprofen) and requires other therapy.
- •Subject has rheumatoid arthritis, psoriatic arthritis, or has been diagnosed with any other disorders that is the primary source of their knee pain, including but not limited to:
- •osteonecrosis, radiculopathy, bursitis, tendinitis, tumor, cancer.
- •Subject has documented history of gout or pseudo-gout.
- •Subject has a known allergy to local anesthetics.
- •Subject has autoimmune disease or a known history of having Acquired Immunodeficiency Syndromes (AIDS) or Human Immunodeficiency Virus (HIV).
- •Subject has diagnosis of hematologic, renal, hepatic, or coagulation abnormalities based on medical history and laboratory results.
- •Subject has received any of the following to the target knee:
Arms & Interventions
AlloGen Liquid
A single-dose, intra-articular (IA) injection of 2.0 mL of AlloGen Liquid administered to the affected knee.
Intervention: AlloGen Liquid
Saline
A single-dose, intra-articular (IA) injection of 2.0 mL of saline administered to the affected knee.
Intervention: Placebo
Outcomes
Primary Outcomes
Evaluate the safety of intra-articular (IA) administration of AlloGen Liquid in the target knee
Time Frame: Baseline to 12 weeks
The incidence of related Adverse Events (AEs), Serious Adverse Events (SAEs), and Unanticipated Adverse Events
Secondary Outcomes
- Evaluate preliminary efficacy of the injection by assessing function(Baseline, 6, 12 and 26 weeks)
- Evaluate preliminary efficacy of the injection by assessing total SF-12 score(Baseline, 6, 12 and 26 weeks)
- Evaluate preliminary efficacy of the injection by assessing total WOMAC(Baseline, 6, 12 and 26 weeks)
- Evaluate preliminary efficacy of the injection by assessing total KOOS score(Baseline, 6, 12 and 26 weeks)
- Evaluate preliminary efficacy of the injection by assessing pain subscale scores(Baseline, 6, 12 and 26 weeks)
- Evaluate preliminary efficacy of the injection by assessing pain(Baseline, 6, 12 and 26 weeks)
- Evaluate preliminary efficacy of the injection by assessing function subscale scores(Baseline, 6, 12 and 26 weeks)
- Evaluate preliminary efficacy of the injection by assessing Patient-Reported Outcomes Measurement Information System (PROMIS)(Baseline, 6, 12 and 26 weeks)
- Evaluate preliminary efficacy of the injection by Visual Analog Scale(Baseline, 6, 12 and 26 weeks)
- Evaluate the safety of intra-articular (IA) administration of AlloGen Liquid in the target knee(26 Weeks)