Safety and Feasibility of Umbilical Cord Wharton's Jelly Allograft Injections for Lumbar Pain
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Enrollment
- 100
- Locations
- 7
- Primary Endpoint
- C-reactive protein
Study Overview
Brief Summary
This is a Pilot Study that is an open label, prospective, non-controlled study in which the safety and feasibility of Wharton's Jelly (WJ) allograft will be evaluated in 100 participants suffering with low back pain.
Detailed Description
This is a prospective, open label, non-controlled Pilot study in which the safety and feasibility of umbilical cord Wharton's Jelly (WJ) allograft will be evaluated in participants suffering with lumbar pain. The participants will receive a series of lumbar injections described in the protocol.
As this is a Pilot study primarily designed to evaluate safety, no control will be used. The dosing will consist of 10cc WJ Allograft with 100 total participants. In addition to baseline outcome instruments along with imaging and laboratory studies, participants will be followed for one year for evaluation of safety, pain relief and functional improvements.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
Open Label
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient must
- •Be over age
- •Suffering from chronic lumbar pain
- •Body Mass Index (BMI) <50 Kilograms/m
- •Pain score of 4 or more on the Numeric Pain Rating Scale (NPRS).
- •Female participants must be abstinent, surgically sterilized or postmenopausal.
- •Premenopausal females must be 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.
Exclusion Criteria
- •Patient must not
- •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 lumbar symptom modifying drugs during the course of the study without discussing and reporting the use to the site Clinical investigator and study team.
- •Known allergy to penicillin, sulfa or amphotericin medications.
- •Have had any lumbar injections (at all) of any drug in lumbar spine in the past 6 months.
- •Have had surgery on the lumbar spine within the past 6 months.
- •Had a traumatic injury to the lumbar spine 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 5 years.
- •Have a lumbar infection or have used antibiotics for lumbar infection within the past 3 months.
- •Have participated in any other clinical study or treatment (not just for the lumbar spine, but for any reason) with any investigational product within the past 30 days prior to inclusion of study.
- •Female participants 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.
Outcomes
Primary Outcomes
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.
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.
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
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.
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
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
Secondary Outcomes
- The Patient-specific functional scale (PSFS)(Baseline, 1 week, 6 weeks, 3 months, 6 months, 1 year)
- 36-Item Short Form Survey (SF-36)(Baseline, 24 hours after intervention, 1 week, 6 weeks, 3 months, 6 months, 1 year)
- Oswestry disability index (ODI)(Baseline, 1 week, 6 weeks, 3 months, 6 months, 1 year)
- Roland Morris disability questionnaire (RMQ)(Baseline, 1 week, 6 weeks, 3 months, 6 months, 1 year)
- Numerical Pain Rating Scale (NPRS)(Baseline, 24 hours after intervention, 1 week, 6 weeks, 3 months, 6 months, 1 year)