Safety and Feasibility of Umbilical Cord Wharton's Jelly Allograft Injections for Knee Osteoarthritis
This study is testing the safety and how well a treatment called Umbilical Cord Wharton's Jelly Allograft works for people with knee osteoarthritis. This treatment involves injecting a biologic (a substance made from living organisms) directly into your knee joint. The study is looking at different doses of this injection – low, medium, and high. You might be able to join if you are over 30, have been diagnosed with moderate knee osteoarthritis (Grade II or III), have a Body Mass Index (BMI) under 50, and experience knee pain. The study will measure C-reactive protein (a marker of inflammation), erythrocyte sedimentation rate (another inflammation marker), and alanine transaminase (an enzyme that can indicate liver health) to see the treatment's effects. This is a pilot study, meaning it's an early step to see if the treatment is safe and practical.
- Study design
- This is a randomized, open-label pilot study with 120 participants. Participants will be assigned to one of three groups receiving different doses of the injection.
- What's involved
- Participants will receive one intra-articular knee injection. You will have follow-up visits and tests at baseline, 1 week, 6 weeks, 3 months, 6 months, and one year after the procedure.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for one year after the procedure to evaluate safety, pain relief, and functional improvements.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Safety and Feasibility of Umbilical Cord Wharton's Jelly Allograft Injections for Knee Osteoarthritis
At a glance
Conditions
NCT06608134
Where you'd take part
This study runs at 5 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Dr. Duc (Steve) Le, MD
Cleveland, Texasstudy coordinator listed
Recruiting
Optimal Medical Group
Fresno, Californiastudy coordinator listed
Recruiting
R3 Anti Aging Beverly Hills
Beverly Hills, Californiastudy coordinator listed
Recruiting
R3 Anti Aging Scottsdale
Scottsdale, Arizonastudy coordinator listed
Recruiting
Scheer Medical Wellness
New York, New Yorkstudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Who to contact
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Inclusion
Exclusion
What this trial measures
- C Reactive ProteinBaseline, 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 RateBaseline, 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 TransaminaseBaseline, 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 TransaminaseBaseline, 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 PhosphataseBaseline, 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
- AlbuminBaseline, 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.
- CreatinineBaseline, 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 NitrogenBaseline, 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.