NCT06608134 · R3 Medical Research
Safety and Feasibility of Umbilical Cord Wharton's Jelly Allograft Injections for Knee Osteoarthritis
What this study is about
This is a Pilot Study which is randomly assigned, forward-looking, open label, gradually increasing doses, non-controlled evaluating safety and feasibility of intra-articular Wharton's Jelly (WJ) allograft will be evaluated in patients suffering with knee osteoarthritis.
View original scientific 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.
Interventions
BIOLOGICAL
Umbilical Cord Wharton's Jelly Allograft Intra-articular Knee Injection
Direct injection of biologic into the knee joint.
Primary outcome measures
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.
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
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.
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
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
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.
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
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Scottsdale, Arizona
- Beverly Hills, California
- Fresno, California
- New York, New York
- Cleveland, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 23, 2024 · Source of record for eligibility and locations