RECRUITING

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

Conditions

Osteoarthritis, Knee umbilical cord Whartons Jelly Allograft knee pain knee arthritis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-10-01

Study Completion:2029-10-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06608134

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.

Ages Eligible for Study:30 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Locations (Sites)

R3 Anti Aging Scottsdale

Scottsdale, Arizona, 85262

United States

R3 Anti Aging Beverly Hills

Beverly Hills, California, 90210

United States

Optimal Medical Group

Fresno, California, 93722

United States

Scheer Medical Wellness

New York, New York, 10036

United States

Dr. Duc (Steve) Le, MD

Cleveland, Texas, 77327

United States

Collaborators and Investigators

Sponsor: R3 Medical Research

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 Registration Dates

Study Start Date2024-10-01

Study Completion Date2029-10-01

Study Record Updates

Study Start Date2024-10-01

Study Completion Date2029-10-01

Terms related to this study

Keywords Provided by Researchers

umbilical cord
Whartons Jelly
Allograft
knee pain
knee arthritis

Additional Relevant MeSH Terms

Osteoarthritis, Knee