Study of AlloGen® Liquid Intra-articular Injection for Knee Osteoarthritis

NCT04835389 | Withdrawn Phase 1 DMC FDA Drug

• 1 other identifier: AT-2021-001
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Osteoarthritis, Knee

Keywords

osteoarthritis; biologic

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline to 12 weeks

Secondary Outcomes (10)

• 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 function 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

  Baseline, 6, 12 and 26 weeks

• Evaluate preliminary efficacy of the injection by Visual Analog Scale

  Baseline, 6, 12 and 26 weeks

Study Arms (2)

AlloGen Liquid

EXPERIMENTAL

A single-dose, intra-articular (IA) injection of 2.0 mL of AlloGen Liquid administered to the affected knee.

Biological: AlloGen Liquid

Saline

PLACEBO COMPARATOR

A single-dose, intra-articular (IA) injection of 2.0 mL of saline administered to the affected knee.

Drug: Placebo

Interventions

AlloGen Liquid BIOLOGICAL

Amniotic fluid

AlloGen Liquid

Placebo DRUG

0.9% normal saline

Saline

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• Intra-articular hyaluronic acid (HA) injection within 12 weeks prior to screening;
• Steroid or platelet rich plasma (PRP) injection within 12 weeks prior to screening;
• Has had or is planning to have major surgery in the target knee within 26 weeks of treatment; or
• History of unicondylar or total knee arthroplasty.
• Subject is currently participating in another clinical trial or has used an investigational drug, device or biologic within 12 weeks prior to treatment.

Sponsors & Collaborators

• VIVEX Biologics, Inc.: lead
• MCRA: collaborator

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Brian Cole, MD

  Brian Cole MD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Subjects and investigators (including outcomes assessment) will be blinded to the treatment arm that is assigned.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, Placebo-Controlled, Double-Blinded

Study Record Dates

• First Submitted: December 11, 2020
• First Posted: April 8, 2021
• Study Start: June 1, 2021
• Primary Completion: March 1, 2022
• Study Completion: June 30, 2022
• Last Updated: July 8, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share