Safety and Feasibility of Umbilical Cord Wharton's Jelly Allograft Injections for Knee Osteoarthritis

September 19, 2024 updated by: R3 Medical Research

Safety and Feasibility of Umbilical Cord Wharton's Jelly Allograft Injections for

This is a Pilot Study which is randomized, prospective, open label, dose escalation, non-controlled evaluating safety and feasibility of intra-articular Wharton's Jelly (WJ) allograft will be evaluated in patients suffering with knee osteoarthritis. The participants will be randomized to one of three dosing treatment arms that will consist of one intra-articular knee injection containing either low dose, medium dose or high dose WJ allograft tissue.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a Pilot Study which is randomized, prospective, open label, dose escalation, non-controlled study in which the safety and feasibility of intra-articular Wharton's Jelly (WJ) allograft will be evaluated in patients suffering with knee OA. The participants will be randomized to one of three dosing treatment arms that will consist of one intra-articular knee injection containing either low dose, medium dose or high dose WJ allograft tissue.

As this is a Pilot Study primarily designed to evaluate safety, no control will be used. The dosing groups will consist of either 2cc WJ Allograft (Low Dose), 3cc WJ Allograft (Medium Dose), or 4cc WJ Allograft (High Dose) with 120 total patients randomized into the three arms equally. In addition to baseline outcome instruments along with imaging and laboratory studies, patients will be followed for one year for evaluation of safety, pain relief and functional improvements.

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85262
    • California
      • Beverly Hills, California, United States, 90210
        • Recruiting
        • R3 Anti Aging Beverly Hills
        • Contact:
      • Fresno, California, United States, 93722
        • Recruiting
        • Optimal Medical Group
        • Contact:
    • New York
      • New York, New York, United States, 10036
        • Recruiting
        • Scheer Medical Wellness
        • Contact:
    • Texas
      • Cleveland, Texas, United States, 77327
        • Recruiting
        • Dr. Duc (Steve) Le, MD
        • Contact:
        • Sub-Investigator:
          • Duc L, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Be over age 30
  • Diagnosed with Grade II or III OA on the KL scale (in one knee).
  • Body Mass Index (BMI) <50Kg/m2
  • Pain score of 4 or more on the Numeric Pain Rating Scale (NPRS)
  • Female patients must be abstinent, surgically sterilized or postmenopausal
  • Premenopausal females must have a negative pregnancy test, on contraceptive measures and do not anticipate pregnancy during the duration of the study.
  • Be willing and capable of giving written informed consent to participate in English.
  • Be willing and capable of complying with study-related requirements, procedures and visits in English.

Exclusion Criteria:

  • Have taken any pain medication including nonsteroidal anti-inflammatory drugs (NSAIDs) within 2 weeks prior to study injection date.
  • Use anticoagulants have a substance abuse history and fail to agree not to take any knee-symptom modifying drugs during the course of the study without discussing and reporting the use to the site principal investigator and study team.
  • Have had an intra-articular injection of any drug including viscosupplementation in the index knee in the past 6 months.
  • Have had surgery on the index knee with the past 6 months.
  • Had a traumatic injury to the index knee with the past 3 months.
  • Planned elective surgery during the course of the study.
  • A history of organ or hematologic transplantation, rheumatoid arthritis, or other autoimmune disorders.
  • Be on immunosuppressive medications.
  • Have a diagnosis of carcinoma with the past 2 years.
  • Have a knee infection or have used antibiotics for knee infection within the past 3 months.
  • Have participated in any other clinical trial or treatment (not just for the knee, but for any reason) with any investigational product within the past 30 days prior to inclusion of study.
  • Female patients who are breast feeding or are pregnant or desire to become pregnant during the course of the study.
  • Contraindications to radiographic or MRI imaging.
  • Serious neurological, psychological or psychiatric disorders.
  • Injury or disability claims under current litigation or pending or approved workers compensation claims.
  • Have a known drug allergy to amphotericin-B, ciprofloxacin, gentamycin, penicillin, or streptomycin.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 2cc WJ Allograft (Low Dose)
The 2cc Whartons Jelly Allograft group receives an intra-articular knee injection and is considered the Low Dose Group.
Biological: Umbilical Cord Wharton's Jelly Allograft Intra-articular Knee Injection
Direct injection of biologic into the knee joint.
Active Comparator: 3cc WJ Allograft (Medium Dose)
The 3cc Whartons Jelly Allograft group receives an intra-articular knee injection and is considered the Medium Dose Group.
Biological: Umbilical Cord Wharton's Jelly Allograft Intra-articular Knee Injection
Direct injection of biologic into the knee joint.
Active Comparator: 4cc WJ Allograft (High Dose)
The 4cc Whartons Jelly Allograft group receives an intra-articular knee injection and is considered the High Dose Group.
Biological: Umbilical Cord Wharton's Jelly Allograft Intra-articular Knee Injection
Direct injection of biologic into the knee joint.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Albumin
Time Frame: Baseline, 1 week after the procedure, 6 weeks, 3 months, 6 months and one year
Albumin is a protein made in the liver. Normal range is 34 to 54 grams/liter.
Baseline, 1 week after the procedure, 6 weeks, 3 months, 6 months and one year
Creatinine
Time Frame: Baseline, 1 week after the procedure, 6 weeks, 3 months, 6 months and one year
Creatinine is a waste product that comes from the digestion of protein in your food and the normal breakdown of muscle tissue. It is removed from the blood through your kidneys. Everyone has some creatinine in their blood, but too much can be a sign of a possible kidney problem. Normal range is 0.6-1.3 milligrams/deciliter
Baseline, 1 week after the procedure, 6 weeks, 3 months, 6 months and one year
C Reactive Protein
Time Frame: Baseline, 1 week after the procedure, 6 weeks, 3 months, 6 months and one year

C-reactive protein (CRP) is a protein made by the liver. The level of CRP increases when there's inflammation in the body. A simple blood test can check your C-reactive protein level.

C-reactive protein is measured in milligrams per liter (mg/L). Results equal to or greater than 8 mg/L or 10 mg/L are considered high. Range values vary depending on the lab doing the test.

A high test result is a sign of inflammation. It may be due to serious infection, injury or chronic disease. Your health care provider may recommend other tests to determine the cause.
Baseline, 1 week after the procedure, 6 weeks, 3 months, 6 months and one year
Erythrocyte Sedimentation Rate
Time Frame: Baseline, 1 week after the procedure, 6 weeks, 3 months, 6 months and one year

Sed rate, or erythrocyte sedimentation rate (ESR), is a blood test that can show inflammatory activity in the body.

Because a sed rate test can't pinpoint the problem that's causing inflammation in your body, it's often accompanied by other blood tests, such as the C-reactive protein (CRP) test.

ESR is measured in millimeters per hour (mm/hr). The normal values are:

0 to 15 mm/hr in men 0 to 20 mm/hr in women
Baseline, 1 week after the procedure, 6 weeks, 3 months, 6 months and one year
Alanine Transaminase
Time Frame: Baseline, 1 week after the procedure, 6 weeks, 3 months, 6 months and one year

ALT is an enzyme that converts proteins into energy for the liver cells. Aspartate transaminase (AST). AST is an enzyme that helps the body break down amino acids. Alkaline phosphatase (ALP). ALP is an enzyme important for breaking down proteins. Albumin and total protein. Albumin is a protein made in the liver. Bilirubin. Bilirubin is a substance produced during the breakdown of red blood cells. Gamma-glutamyltransferase (GGT). Higher-than-usual may mean liver damage. L-lactate dehydrogenase (LD). LD is an enzyme found in the liver. Prothrombin time (PT). PT is the time it takes your blood to clot. Standard range:

Alanine transaminase (ALT). ALT is an enzyme that converts proteins into energy for the liver cells. Standard range:

ALT. 7 to 55 units per liter U/L.
Baseline, 1 week after the procedure, 6 weeks, 3 months, 6 months and one year
Aspartate Transaminase
Time Frame: Baseline, 1 week after the procedure, 6 weeks, 3 months, 6 months and one year
AST is an enzyme that helps the body break down amino acids. . Standard range: AST 8 to 48 units per liter
Baseline, 1 week after the procedure, 6 weeks, 3 months, 6 months and one year
Alkaline Phosphatase
Time Frame: Baseline, 1 week after the procedure, 6 weeks, 3 months, 6 months and one year
ALP is an enzyme important for breaking down proteins. Standard range: 40 to 129 units per liter
Baseline, 1 week after the procedure, 6 weeks, 3 months, 6 months and one year
Blood Urea Nitrogen
Time Frame: Baseline, 1 week after the procedure, 6 weeks, 3 months, 6 months and one year
blood urea nitrogen (BUN) test reveals important information about how well your kidneys are working. A BUN test measures the amount of urea nitrogen that's in your blood. Normal BUN is 6-20 milligrams/deciliter.
Baseline, 1 week after the procedure, 6 weeks, 3 months, 6 months and one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
36-Item Short Form Survey (SF-36)
Time Frame: Baseline, 24 hours after intervention, 1 week, 6 weeks, 3 months, 6 months, 1 year
The SF-36 is used as an assessment tool to measure a quality of life. The SF-36 is comprehensive health survey with a total of 36 questions divided into eight categories, including physical functioning (10 items), bodily pain (2 items), role limitations due to physical health problems (4 items), role limitations due to personal or emotional problems (4 items), emotional well-being (5 items), social functioning (2 items), energy/fatigue (4 items), and general health perceptions (5 items). The score averages for each category range from 0 to 100, with a higher score defining a more favorable outcome.
Baseline, 24 hours after intervention, 1 week, 6 weeks, 3 months, 6 months, 1 year
Numerical Pain Rating Scale (NPRS)
Time Frame: Baseline, 24 hours after intervention, 1 week, 6 weeks, 3 months, 6 months, 1 year
The Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).
Baseline, 24 hours after intervention, 1 week, 6 weeks, 3 months, 6 months, 1 year
Knee Injury and Osteoarthritis Outcome Score
Time Frame: Baseline, 24 hours after intervention, 1 week, 6 weeks, 3 months, 6 months, 1 year
This survey asks for your view about your knee. This information will help us keep track of how you feel about your knee and how well you are able to perform your usual activities.
Baseline, 24 hours after intervention, 1 week, 6 weeks, 3 months, 6 months, 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

R3 Medical Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2024

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

October 1, 2029

Study Registration Dates

First Submitted

September 19, 2024

First Submitted That Met QC Criteria

September 19, 2024

First Posted (Actual)

September 23, 2024

Study Record Updates

Last Update Posted (Actual)

September 23, 2024

Last Update Submitted That Met QC Criteria

September 19, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R3-WJI-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

R3 Medical Research will share study materials in a blinded fashion with no participant identifying information to participating researchers as needed.

IPD Sharing Time Frame

Short term (6 months) and Long Term (12 months) for one month only.

IPD Sharing Access Criteria

Secure, encrypted server.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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