Trial studying safety and effects for Osteoarthritis, Knee
Official title Safety and Feasibility of Umbilical Cord Wharton's Jelly Allograft Injections for Knee Osteoarthritis
ClinicalTrials.gov ID: NCT06608134
What this study is testing
What is Umbilical Cord Wharton's Jelly Allograft Intra-articular Knee Injection?
This is an investigational injection being studied as a potential treatment for knee osteoarthritis.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study checks if it is safe and possible to use injections of tissue from umbilical cords to treat knee arthritis. It also looks at how different amounts of the tissue work.
- Who it's for
- People who have knee arthritis.
- What's involved
- Participants will get one injection into their knee. The injection contains tissue from umbilical cords, and the amount varies by group.
- Time commitment
- The study involves one injection and follow-up visits to check for safety.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 30 and older
You may be able to join 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
You likely can't join 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...
- 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.
See the full eligibility 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...
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Scottsdale, Arizona, United States
- Beverly Hills, California, United States
- Fresno, California, United States
- New York, New York, United States
- Cleveland, Texas, United States
Compensation & support
This study's listing mentions compensation or reimbursement.
No amount is published here because ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team, so confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 30 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Scottsdale, Arizona, United States; Beverly Hills, California, United States; Fresno, California, United States; New York, New York, United States; Cleveland, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.