Osteoarthritis, Knee
Conditions
Keywords
umbilical cord, Whartons Jelly, Allograft, knee pain, knee arthritis
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.
Detailed description
This is a Pilot Study which is randomized, prospective, open label, dose escalation, non-controlled study in which the safety and feasibility of intra-articular Wharton's Jelly (WJ) allograft will be evaluated in patients suffering with knee OA. 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. As this is a Pilot Study primarily designed to evaluate safety, no control will be used. The dosing groups will consist of either 2cc WJ Allograft (Low Dose), 3cc WJ Allograft (Medium Dose), or 4cc WJ Allograft (High Dose) with 120 total patients randomized into the three arms equally. In addition to baseline outcome instruments along with imaging and laboratory studies, patients will be followed for one year for evaluation of safety, pain relief and functional improvements.
Interventions
BIOLOGICALUmbilical Cord Wharton's Jelly Allograft Intra-articular Knee Injection
Direct injection of biologic into the knee joint.
Sponsors
R3 Medical Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
With double blinding of the allograft neither participant nor provider will know what is being administered.
Intervention model description
randomized, prospective, open label, dose escalation, non-controlled
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood Urea Nitrogen | 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. |
| Alkaline Phosphatase | 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 | 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 | 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 |
| C Reactive Protein | 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 | 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 | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Numerical Pain Rating Scale (NPRS) | Baseline, 24 hours after intervention, 1 week, 6 weeks, 3 months, 6 months, 1 year | The Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain). |
| Knee Injury and Osteoarthritis Outcome Score | Baseline, 24 hours after intervention, 1 week, 6 weeks, 3 months, 6 months, 1 year | This survey asks for your view about your knee. This information will help us keep track of how you feel about your knee and how well you are able to perform your usual activities. |
| 36-Item Short Form Survey (SF-36) | Baseline, 24 hours after intervention, 1 week, 6 weeks, 3 months, 6 months, 1 year | The SF-36 is used as an assessment tool to measure a quality of life. The SF-36 is comprehensive health survey with a total of 36 questions divided into eight categories, including physical functioning (10 items), bodily pain (2 items), role limitations due to physical health problems (4 items), role limitations due to personal or emotional problems (4 items), emotional well-being (5 items), social functioning (2 items), energy/fatigue (4 items), and general health perceptions (5 items). The score averages for each category range from 0 to 100, with a higher score defining a more favorable outcome. |
Countries
United States
Outcome results
None listed