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Osteoarthritis, KneePhase 1NCT04835389

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

A Phase 1 study testing AlloGen Liquid in people with Osteoarthritis, Knee, run by VIVEX Biologics, Inc..

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Osteoarthritis, Knee
What is being tested?
AlloGen Liquid
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
No sites listed yet
Study dates
1 Jun 2021to 30 Jun 2022
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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 .

About this study

Official title: A Phase 1 Study Evaluating the Safety and Preliminary Efficacy of AlloGen® Liquid Intra-articular Injection for Knee Osteoarthritis

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.

Read the 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.

Being tested
AlloGen Liquid, Placebo
Keywords
osteoarthritis, biologic
Medical subject headings
Osteoarthritis, Knee, Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AlloGen LiquidBiological

    Amniotic fluid

  • PlaceboDrug

    0.9% normal saline

Study groups in NCT04835389
Study groupRoleWhat they receive
AlloGen LiquidExperimentalA single-dose, intra-articular (IA) injection of 2.0 mL of AlloGen Liquid administered to the affected knee.
Receives: Biological: AlloGen Liquid
SalinePlacebo comparatorA single-dose, intra-articular (IA) injection of 2.0 mL of saline administered to the affected knee.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Baseline to 12 weeks

Secondary outcomes (10)

  1. Evaluate preliminary efficacy of the injection by assessing pain subscale scores

    Composite change from baseline in WOMAC-A (pain subscale) scores

    Measured: Baseline, 6, 12 and 26 weeks

  2. Evaluate preliminary efficacy of the injection by assessing function subscale scores

    Composite change from baseline in WOMAC-C (function subscale) score

    Measured: Baseline, 6, 12 and 26 weeks

  3. Evaluate preliminary efficacy of the injection by assessing pain

    Change from baseline in WOMAC-A scores

    Measured: Baseline, 6, 12 and 26 weeks

  4. Evaluate preliminary efficacy of the injection by assessing function

    Change from baseline in WOMAC-C score

    Measured: Baseline, 6, 12 and 26 weeks

  5. Evaluate preliminary efficacy of the injection by Visual Analog Scale

    Change from baseline in Visual Analog Scale (VAS)

    Measured: Baseline, 6, 12 and 26 weeks

  6. Evaluate preliminary efficacy of the injection by assessing total WOMAC

    Change from baseline in total WOMAC score

    Measured: Baseline, 6, 12 and 26 weeks

  7. 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

    Measured: 26 Weeks

  8. 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

    Measured: Baseline, 6, 12 and 26 weeks

  9. Evaluate preliminary efficacy of the injection by assessing total SF-12 score

    Change from baseline in total SF-12 score

    Measured: Baseline, 6, 12 and 26 weeks

  10. Evaluate preliminary efficacy of the injection by assessing total KOOS score

    Change from baseline in total KOOS score

    Measured: Baseline, 6, 12 and 26 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2021
  2. Study start1 Jun 2021 (estimated)
  3. Primary completion1 Mar 2022 (estimated)
  4. Study completion30 Jun 2022 (estimated)

Why it stopped: Company decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized, Placebo-Controlled, Double-Blinded
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04835389
Sponsor's protocol ID
AT-2021-001
Status last verified
Jul 2021
First submitted
11 Dec 2020
Last updated
8 Jul 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AlloGen Liquid in people with Osteoarthritis, Knee, run by VIVEX Biologics, Inc..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 8 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluate the safety of intra-articular (IA) administration of AlloGen Liquid in the target knee (time frame: Baseline to 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04835389.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2021.

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