Recruiting
Early Phase 1

Wharton's Jelly

Sponsor:

R3 Medical Research

Code:

NCT06608134

Conditions

Osteoarthritis, Knee

Eligibility Criteria

Sex: All

Age: 30+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

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

Study ID

NCT06608134

Start date

Oct 1, 2024

Status verified date

Sep, 2024

Completion date

Oct 1, 2029

Anticipated

Primary completion date

Oct 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30+

Healthy Volunteers: Not accepted

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 Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

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.

Interventions

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

Direct injection of biologic into the knee joint.

Primary outcome measure

  • C Reactive Protein [ Time Frame: 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 ]
  • Alanine Transaminase [ Time Frame: 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 ]
  • Alkaline Phosphatase [ Time Frame: Baseline, 1 week after the procedure, 6 weeks, 3 months, 6 months and one year ]
  • Albumin [ Time Frame: 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 ]
  • Blood Urea Nitrogen [ Time Frame: Baseline, 1 week after the procedure, 6 weeks, 3 months, 6 months and one year ]

Central Contacts and Locations

Locations

R3 Anti Aging Scottsdale

Recruiting

Scottsdale, Arizona, United States, 85262

Contacts

Dr. Sabrina Solt, NMD

480-306-6256info@r3medicalresearch.com

R3 Anti Aging Beverly Hills

Recruiting

Beverly Hills, California, United States, 90210

Contacts

Neville Campbell, MD

424-382-1074info@r3medicalresearch.com

Optimal Medical Group

Recruiting

Fresno, California, United States, 93722

Contacts

Dr. Lucia Mireles-Chavez, MD

559-425-1118info@r3medicalresearch.com

Scheer Medical Wellness

Recruiting

New York, New York, United States, 10036

Contacts

Dr. Alexandre Scheer, MD

212-391-8080info@r3medicalresearch.com

Dr. Duc (Steve) Le, MD

Recruiting

Cleveland, Texas, United States, 77327

Contacts

Duc Le, MD

281-593-1500info@r3medicalresearch.com

More Information

Sponsor

R3 Medical Research

Last update posted

Sep 23, 2024

Last verified

Sep, 2024

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by R3 Medical Research on 2024-09-23.