Status:
WITHDRAWN
Study of AlloGen® Liquid Intra-articular Injection for Knee Osteoarthritis
Lead Sponsor:
VIVEX Biologics, Inc.
Collaborating Sponsors:
MCRA
Conditions:
Osteoarthritis, Knee
Eligibility:
All Genders
18-85 years
Phase:
PHASE1
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, 1...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
- Subject has a history of immunosuppressive use or chemotherapy in the last 12 months.
- Subject has had prior radiation to the index knee.
- Subject is currently taking anticoagulant therapy (excluding Plavix or Aspirin).
- Subject is breast feeding or pregnant or plans to become pregnant within 12 weeks of treatment.
- Subject has any significant medical condition that, in the opinion of the Investigator, would increase the chances of an adverse event and/or would interfere with protocol evaluation and participation.
- Subject is a worker's compensation patient.
- Subject has taken pain medication \<48 hours prior to the injection or has received pain medicine other than acetaminophen and/or NSAIDs for conditions unrelated to OA of the index knee.
- Subject has a history of alcohol or substance abuse.
- Physical or IA injection exclusion criteria include:
- Frank mechanical symptoms such as locking, intermittent block to range of motion, or loose body sensations (meniscal displacement or IA loose body),
- Knee surgery on index knee within 12 months or on contralateral knee within 6 months, and/or
- Acute injury to the knee within 3 months.
- Subject has uncontrolled, unstable diabetes mellitus with HbA1C =/\>8%.
- History within preceding 5 years of solid organ or hematologic transplantation or diagnosis of non-basal cell malignancy.
- History within the preceding 6 months of septic arthritis in the affected knee or sepsis/bacteremia.
- History within the preceding 3 months of infection requiring antibiotic treatment .
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04835389
Start Date
June 1 2021
End Date
June 30 2022
Last Update
July 8 2021
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