Safety and Feasibility of Umbilical Cord Wharton's Jelly Allograft Injections for Lumbar Pain

BIOLOGICAL

Lumbar Injections with 10cc's of Wharton's Jelly Allograft

Low Back Injections with Minimal Manipulation Umbilical Cord Tissue

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 (ALT)

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 (AST)

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 (ALP)

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 (BUN)

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.

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.