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pAF for the Treatment of Osteoarthritis

Primary Purpose

Osteo Arthritis Knee

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Amniotic Fluid Injection
Standard of Care
Sponsored by
University of Utah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteo Arthritis Knee focused on measuring Amniotic Fluid, Osteo Arthritis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients who are between the ages of 18-70 years
  • A confirmed diagnosis of knee osteoarthritis based on clinical and radiographic findings consistent with Kellgren-Lawrence Stage 2-3 disease
  • Patients who have failed conservative treatment (e.g. steroid, activity modification, therapy, etc.) within 3 months
  • Unilateral or bilateral chronic knee joint pain >4 months
  • Patients who are able to ambulate (i.e. not wheelchair bound)
  • Patient reported a typical pain of at least 4 out of 10 during the past week using VAS numeric pain scale (0-10)
  • Patients who are of childbearing potential must agree to use adequate contraception for 90 days after study drug injection

Exclusion Criteria:

  • Subjects who have had a previous injection (i.e. steroid, platelet rich plasma, or other) within the last 3 months
  • A focal chondral defect, defined by x-ray evaluation
  • BMI >40 as defined by NIH Clinical Guidelines Body Mass Index
  • Concurrent participation in another investigational trial involving systemic administration of agents (within the previous 30 days) or plans to participate in any other allogeneic stem cell therapy trial during the 12 month follow-up period
  • Clinical suspicion of infection at injection site
  • Any surgeries within 4 weeks, other than diagnostic surgery
  • Insulin or self-reported non-insulin dependent diabetic evident of HgA1c ≥8% among known diabetics
  • Unable to consent to an English Language Consent Form
  • Frank mechanical issues (i.e. locking of the knee)
  • Workman's Compensation cases
  • Rheumatoid arthritis
  • Patients with a known allergy to local anesthetics or components of the study drug (pAF or steroid injection)
  • Patients with vascular claudication or neurologic disorders affecting the index lower limb
  • Patients with inflammatory arthropathies or connective tissue disorders; or
  • Patients with known alcohol or drug abuse or dependence, recreational use of illicit drug or prescription medications, or have used medical marijuana within 7 days of study enrollment
  • Patients with history of active cancer/malignancy within 2 years of screening, apart from adequately treated basal cell or squamous cell carcinoma of the skin not associated with the target knee
  • Women who are nursing or pregnant
  • Patients of childbearing potential who are unwilling to use adequate contraception for 90 days after study drug injection

Sites / Locations

  • University of Utah Orthopedic CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Amniotic Fluid Injection

Standard of Care Steroid Injection

Arm Description

Amniotic Fluid Injection, 3ml, one time dose.

Corticosteroids, 3ml, one time dose.

Outcomes

Primary Outcome Measures

Repeat allogeneic intra-articular injection within 6 months.
Participants in both the SOC and pAF treatment arms may require and/or request rescue medication (i.e. SOC injection) at any time and will be given per PI discretion as part of standard of care. The clinicians will not know which study arm the study participant is in but will treat the participant with the SOC injection. This information will be documented and collected in the Electronic Medical Record (EMR), as well as the study's electronic data capture system. Participants will not be given any additional pAF injections throughout the study period. The participant will continue to be treated with SOC injections as needed. The outcome will be an indicator of whether or not a subject received a rescue medication within 6 months.

Secondary Outcome Measures

Knee Injury and Osteoarthritis Outcome Score (KOOS)
Scale 0-100, where higher numbers indicate less problems. The KOOS is a survey that assesses joint symptoms, pain, pain during daily activities, physical function in daily living, as well as physical function during sports or recreational activities.
Visual Analog Scale for pain (VAS Pain)
Scale 0-10, where higher numbers indicate more pain. Pain will be measured by the Visual Analog Scale for pain (VAS Pain). This will consist of a comparison of mean values for VAS scoring scales pre-injection and at the 6 month follow-up assessment. Clinically significant outcomes will be determined based on the minimal clinically important difference (MCID) occurring for each respective scale, which is defined as the smallest reported measurement tool used to quantify perceived level of pain, graded on a scale from 0 to 10 with 0 representing no pain and 10 representing the worse pain possible, and with precise measurement of the marked pain level's distance from 0 comprising the pain level.
Single Assessment Numerical Evaluation (SANE)
Scale 0-100, where higher numbers indicate more pain. The SANE asks the patient to evaluate their percentage of normal on the affected joint of region of interest. This is a one-question survey.
Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function Computer Adaptive Test (PF-CAT)
Scale 0-100, where higher numbers indicate better physical functioning. The PF-CAT is a bank of questions related to physical function. It is a computerized adaptive test that asks the patient to self-report capabilities rather than actual performance of physical activities. It includes functioning of upper extremities, lower extremities, and central regions and also assess instrumental activities of daily living, such as running errands.

Full Information

First Posted
April 29, 2021
Last Updated
June 12, 2023
Sponsor
University of Utah
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1. Study Identification

Unique Protocol Identification Number
NCT04886960
Brief Title
pAF for the Treatment of Osteoarthritis
Official Title
A Phase I/II Randomized Double-Blinded Standard of Care (Corticosteroid) vs. Sterile Amniotic Fluid for Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 8, 2021 (Actual)
Primary Completion Date
July 30, 2024 (Anticipated)
Study Completion Date
July 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a Phase I/II Randomized Double-Blinded Standard of Care (Corticosteroid) vs. Sterile Amniotic Fluid for Osteoarthritis
Detailed Description
This study will look at blinded standard of care (SOC) steroid injection vs. amniotic fluid injection (pAF) to treat and reduce osteoarthritis (OA) inflammation and pain. The main objectives of this study are to establish the safety and tolerability of allogeneic intra-articular pAF injections. Secondary objectives include pain levels and functional outcome scoring in patients over a 12 month time frame.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteo Arthritis Knee
Keywords
Amniotic Fluid, Osteo Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Masking Description
Half of the patients will be in the SOC treatment arm and half of the patients will be in the AF arm. The PI and patients will be blinded as to the arm in which they will be participating. Once the randomization number is obtained, unblinded research staff will prepare the appropriate study drug. The injections will be blinded to the research coordinator in charge of data entry, the treating physician and the patient.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Amniotic Fluid Injection
Arm Type
Experimental
Arm Description
Amniotic Fluid Injection, 3ml, one time dose.
Arm Title
Standard of Care Steroid Injection
Arm Type
Active Comparator
Arm Description
Corticosteroids, 3ml, one time dose.
Intervention Type
Biological
Intervention Name(s)
Amniotic Fluid Injection
Other Intervention Name(s)
Processed Amniotic Fluid, pAF, Human Amniotic Fluid, hAF
Intervention Description
Comparison of Standard of Care (Corticosteroid) injection vs. Sterile Processed Amniotic Fluid Injection for Knee Osteoarthritis
Intervention Type
Other
Intervention Name(s)
Standard of Care
Other Intervention Name(s)
Corticosteriods 3ml, one time dose
Intervention Description
Comparison of Standard of Care (Corticosteroid) injection vs. Sterile Processed Amniotic Fluid Injection for Knee Osteoarthritis
Primary Outcome Measure Information:
Title
Repeat allogeneic intra-articular injection within 6 months.
Description
Participants in both the SOC and pAF treatment arms may require and/or request rescue medication (i.e. SOC injection) at any time and will be given per PI discretion as part of standard of care. The clinicians will not know which study arm the study participant is in but will treat the participant with the SOC injection. This information will be documented and collected in the Electronic Medical Record (EMR), as well as the study's electronic data capture system. Participants will not be given any additional pAF injections throughout the study period. The participant will continue to be treated with SOC injections as needed. The outcome will be an indicator of whether or not a subject received a rescue medication within 6 months.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Description
Scale 0-100, where higher numbers indicate less problems. The KOOS is a survey that assesses joint symptoms, pain, pain during daily activities, physical function in daily living, as well as physical function during sports or recreational activities.
Time Frame
6 months
Title
Visual Analog Scale for pain (VAS Pain)
Description
Scale 0-10, where higher numbers indicate more pain. Pain will be measured by the Visual Analog Scale for pain (VAS Pain). This will consist of a comparison of mean values for VAS scoring scales pre-injection and at the 6 month follow-up assessment. Clinically significant outcomes will be determined based on the minimal clinically important difference (MCID) occurring for each respective scale, which is defined as the smallest reported measurement tool used to quantify perceived level of pain, graded on a scale from 0 to 10 with 0 representing no pain and 10 representing the worse pain possible, and with precise measurement of the marked pain level's distance from 0 comprising the pain level.
Time Frame
6 months
Title
Single Assessment Numerical Evaluation (SANE)
Description
Scale 0-100, where higher numbers indicate more pain. The SANE asks the patient to evaluate their percentage of normal on the affected joint of region of interest. This is a one-question survey.
Time Frame
6 months
Title
Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function Computer Adaptive Test (PF-CAT)
Description
Scale 0-100, where higher numbers indicate better physical functioning. The PF-CAT is a bank of questions related to physical function. It is a computerized adaptive test that asks the patient to self-report capabilities rather than actual performance of physical activities. It includes functioning of upper extremities, lower extremities, and central regions and also assess instrumental activities of daily living, such as running errands.
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Number of treatment emergent adverse events (AEs) directly related to the injection.
Time Frame
1 day, 2 days, 1 month, 3 months, 6 months, 12 months
Title
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Description
Scale 0-100, where higher numbers indicate less problems. The KOOS is a survey that assesses joint symptoms, pain, pain during daily activities, physical function in daily living, as well as physical function during sports or recreational activities.
Time Frame
1, 3, 6 and 12 months
Title
Visual Analog Scale for pain (VAS Pain).
Description
Scale 0-10, where higher numbers indicate more pain. Pain will be measured by the Visual Analog Scale for pain (VAS Pain). This will consist of a comparison of mean values for VAS scoring scales pre-injection and at the 6 month follow-up assessment. Clinically significant outcomes will be determined based on the minimal clinically important difference (MCID) occurring for each respective scale, which is defined as the smallest reported measurement tool used to quantify perceived level of pain, graded on a scale from 0 to 10 with 0 representing no pain and 10 representing the worse pain possible, and with precise measurement of the marked pain level's distance from 0 comprising the pain level.
Time Frame
1, 3, 6 and 12 months
Title
Single Assessment Numerical Evaluation (SANE)
Description
Scale 0-100, where higher numbers indicate more pain. The SANE asks the patient to evaluate their percentage of normal on the affected joint of region of interest. This is a one-question survey.
Time Frame
1, 3, 6 and 12 months
Title
Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function Computer Adaptive Test (PF-CAT)
Description
Scale 0-100, where higher numbers indicate better physical functioning, The PF-CAT is a bank of questions related to physical function. It is a computerized adaptive test that asks the patient to self-report capabilities rather than actual performance of physical activities. It includes functioning of upper extremities, lower extremities, and central regions and also assess instrumental activities of daily living, such as running errands.
Time Frame
1, 3, 6 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who are between the ages of 18-70 years A confirmed diagnosis of knee osteoarthritis based on clinical and radiographic findings consistent with Kellgren-Lawrence Stage 2-3 disease Patients who have failed conservative treatment (e.g. steroid, activity modification, therapy, etc.) within 3 months Unilateral or bilateral chronic knee joint pain >4 months Patients who are able to ambulate (i.e. not wheelchair bound) Patient reported a typical pain of at least 4 out of 10 during the past week using VAS numeric pain scale (0-10) Patients who are of childbearing potential must agree to use adequate contraception for 90 days after study drug injection Exclusion Criteria: Subjects who have had a previous injection (i.e. steroid, platelet rich plasma, or other) within the last 3 months A focal chondral defect, defined by x-ray evaluation BMI >40 as defined by NIH Clinical Guidelines Body Mass Index Concurrent participation in another investigational trial involving systemic administration of agents (within the previous 30 days) or plans to participate in any other allogeneic stem cell therapy trial during the 12 month follow-up period Clinical suspicion of infection at injection site Any surgeries within 4 weeks, other than diagnostic surgery Insulin or self-reported non-insulin dependent diabetic evident of HgA1c ≥8% among known diabetics Unable to consent to an English Language Consent Form Frank mechanical issues (i.e. locking of the knee) Workman's Compensation cases Rheumatoid arthritis Patients with a known allergy to local anesthetics or components of the study drug (pAF or steroid injection) Patients with vascular claudication or neurologic disorders affecting the index lower limb Patients with inflammatory arthropathies or connective tissue disorders; or Patients with known alcohol or drug abuse or dependence, recreational use of illicit drug or prescription medications, or have used medical marijuana within 7 days of study enrollment Patients with history of active cancer/malignancy within 2 years of screening, apart from adequately treated basal cell or squamous cell carcinoma of the skin not associated with the target knee Women who are nursing or pregnant Patients of childbearing potential who are unwilling to use adequate contraception for 90 days after study drug injection
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Petron, MD
Phone
801-587-0989
Email
david.petronl@hci.utah.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jan Pierce, MBA
Phone
801-585-9539
Email
jan.pierce@hsc.utah.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Petron, MD
Organizational Affiliation
University of Utah Orthopaedic Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Utah Orthopedic Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Petron, MD
Phone
801-587-0989
Email
david.petronl@hci.utah.edu
First Name & Middle Initial & Last Name & Degree
Bob Toth, PA, ATC
First Name & Middle Initial & Last Name & Degree
Nick Monson, DO
First Name & Middle Initial & Last Name & Degree
John Phillips, PhD
First Name & Middle Initial & Last Name & Degree
Jan Pierce, MBA
First Name & Middle Initial & Last Name & Degree
Christopher Gee, MD, MPH
First Name & Middle Initial & Last Name & Degree
Emily J. Harold, MD
First Name & Middle Initial & Last Name & Degree
Joy English, MD, RMSK
First Name & Middle Initial & Last Name & Degree
Daniel Cushman
First Name & Middle Initial & Last Name & Degree
Amy Powell, MD

12. IPD Sharing Statement

Plan to Share IPD
No
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Links:
URL
https://www.cdc.gov/arthritis/basics/osteoarthritis.htm
Description
Osteoarthritis Fact Sheet. Center for Disease Control and Prevention.

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pAF for the Treatment of Osteoarthritis

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