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

NCT06608134 | Recruiting Early Phase 1 DMC FDA Drug

• 1 other identifier: R3-WJI-001
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Osteoarthritis, Knee

Keywords

umbilical cord; Whartons Jelly; Allograft; knee pain; knee arthritis

Outcome Measures

Primary Outcomes (8)

• C Reactive Protein

  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

  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

  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

  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

  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

• Albumin

  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

  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

• Blood Urea Nitrogen

  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 Outcomes (3)

• 36-Item Short Form Survey (SF-36)

  Baseline, 24 hours after intervention, 1 week, 6 weeks, 3 months, 6 months, 1 year

• Numerical Pain Rating Scale (NPRS)

  Baseline, 24 hours after intervention, 1 week, 6 weeks, 3 months, 6 months, 1 year

• Knee Injury and Osteoarthritis Outcome Score

  Baseline, 24 hours after intervention, 1 week, 6 weeks, 3 months, 6 months, 1 year

Study Arms (3)

2cc WJ Allograft (Low Dose)

ACTIVE COMPARATOR

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

3cc WJ Allograft (Medium Dose)

ACTIVE COMPARATOR

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

4cc WJ Allograft (High Dose)

ACTIVE COMPARATOR

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

Interventions

Umbilical Cord Wharton's Jelly Allograft Intra-articular Knee Injection BIOLOGICAL

Direct injection of biologic into the knee joint.

2cc WJ Allograft (Low Dose); 3cc WJ Allograft (Medium Dose); 4cc WJ Allograft (High Dose)

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• R3 Medical Research: lead

Study Sites (5)

R3 Anti Aging Scottsdale

Scottsdale, Arizona, 85262, United States

RECRUITING

R3 Anti Aging Beverly Hills

Beverly Hills, California, 90210, United States

RECRUITING

Optimal Medical Group

Fresno, California, 93722, United States

RECRUITING

Scheer Medical Wellness

New York, New York, 10036, United States

RECRUITING

Dr. Duc (Steve) Le, MD

Cleveland, Texas, 77327, United States

RECRUITING

Related Publications (16)

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• Rodriguez HC, Gupta M, Cavazos-Escobar E, El-Amin SF 3rd, Gupta A. Umbilical cord: an allogenic tissue for potential treatment of COVID-19. Hum Cell. 2021 Jan;34(1):1-13. doi: 10.1007/s13577-020-00444-5. Epub 2020 Oct 9.

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• Gupta A, Cady C, Fauser AM, Rodriguez HC, Mistovich RJ, Potty AGR, Maffulli N. Cell-free Stem Cell-Derived Extract Formulation for Regenerative Medicine Applications. Int J Mol Sci. 2020 Dec 9;21(24):9364. doi: 10.3390/ijms21249364.

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• Main BJ, Maffulli N, Valk JA, Rodriguez HC, Gupta M, El-Amin SF 3rd, Gupta A. Umbilical Cord-Derived Wharton's Jelly for Regenerative Medicine Applications: A Systematic Review. Pharmaceuticals (Basel). 2021 Oct 27;14(11):1090. doi: 10.3390/ph14111090.

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• Gupta A, El-Amin SF 3rd, Levy HJ, Sze-Tu R, Ibim SE, Maffulli N. Umbilical cord-derived Wharton's jelly for regenerative medicine applications. J Orthop Surg Res. 2020 Feb 13;15(1):49. doi: 10.1186/s13018-020-1553-7.

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MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: With double blinding of the allograft neither participant nor provider will know what is being administered.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: randomized, prospective, open label, dose escalation, non-controlled

Study Record Dates

• First Submitted: September 19, 2024
• First Posted: September 23, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2029
• Last Updated: September 23, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Short term (6 months) and Long Term (12 months) for one month only.
• Access Criteria: Secure, encrypted server.

Locations

US (5)