An Early Phase 1 interventional study of Umbilical Cord Wharton's Jelly Allograft Intra-articular Knee Injection in Osteoarthritis, Knee, sponsored by R3 Medical Research. Recruiting at 5 sites in United States. Open to participants aged 30 Years and older. Per ClinicalTrials.gov, last updated 2024-09-23.
Sponsored by R3 Medical Research · Early Phase 1, Interventional, and Treatment
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.
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.
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's planned enrollment of 120 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →This is the only study on the registry with R3 Medical Research as lead sponsor.
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Exclusion Criteria:
The 2cc Whartons Jelly Allograft group receives an intra-articular knee injection and is considered the Low Dose Group.
Biological: Umbilical Cord Wharton's Jelly Allograft Intra-articular Knee Injection
The 3cc Whartons Jelly Allograft group receives an intra-articular knee injection and is considered the Medium Dose Group.
Biological: Umbilical Cord Wharton's Jelly Allograft Intra-articular Knee Injection
The 4cc Whartons Jelly Allograft group receives an intra-articular knee injection and is considered the High Dose Group.
Biological: Umbilical Cord Wharton's Jelly Allograft Intra-articular Knee Injection
Direct injection of biologic into the knee joint.
C Reactive Protein
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.
Time frame: Baseline, 1 week after the procedure, 6 weeks, 3 months, 6 months and one year
Erythrocyte Sedimentation Rate
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
Time frame: Baseline, 1 week after the procedure, 6 weeks, 3 months, 6 months and one year
Alanine Transaminase
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.
Time frame: Baseline, 1 week after the procedure, 6 weeks, 3 months, 6 months and one year
Aspartate Transaminase
AST is an enzyme that helps the body break down amino acids. . Standard range: AST 8 to 48 units per liter
Time frame: Baseline, 1 week after the procedure, 6 weeks, 3 months, 6 months and one year
Alkaline Phosphatase
ALP is an enzyme important for breaking down proteins. Standard range: 40 to 129 units per liter
Time frame: Baseline, 1 week after the procedure, 6 weeks, 3 months, 6 months and one year
Albumin
Albumin is a protein made in the liver. Normal range is 34 to 54 grams/liter.
Time frame: Baseline, 1 week after the procedure, 6 weeks, 3 months, 6 months and one year
Creatinine
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
Time frame: Baseline, 1 week after the procedure, 6 weeks, 3 months, 6 months and one year
Blood Urea Nitrogen
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.
Time frame: Baseline, 1 week after the procedure, 6 weeks, 3 months, 6 months and one year
36-Item Short Form Survey (SF-36)
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.
Time frame: Baseline, 24 hours after intervention, 1 week, 6 weeks, 3 months, 6 months, 1 year
Numerical Pain Rating Scale (NPRS)
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).
Time frame: Baseline, 24 hours after intervention, 1 week, 6 weeks, 3 months, 6 months, 1 year
Knee Injury and Osteoarthritis Outcome Score
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.
Time frame: Baseline, 24 hours after intervention, 1 week, 6 weeks, 3 months, 6 months, 1 year
Plan to share: Yes — R3 Medical Research will share study materials in a blinded fashion with no participant identifying information to participating researchers as needed.
Supporting information: Study protocol, Icf, Csr
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