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

ConditionLow Back Pain
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age20+
SponsorR3 Stem Cell

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Be over age 20.

Suffering from chronic lumbar pain

Body Mass Index (BMI) <50 Kilograms/m2.

Pain score of 4 or more on the Numeric Pain Rating Scale (NPRS).

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

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

    Biological/Vaccine

    Low Back Injections with Minimal Manipulation Umbilical Cord Tissue

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Lumbar Injection ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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
3

Alanine transaminase (ALT)

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
4

Aspartate transaminase (AST)

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

Secondary outcomes

1

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
2

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
3

Oswestry disability index (ODI)

The Oswestry Disability Index (ODI) is a common questionnaire used to evaluate functional outcomes and physical functioning in patients with acute or chronic low back pain. This questionnaire yields a subjective percentage score that grades the level of physical function or disability. The cumulative score indicates the patient as functioning at a point on a range from minimal disability to bedbound. Each item consists of 6 statements (scores 0-5) and is scored by the patient in reference to his/her current functional status. A sum is formed from the points given, which is then divided by the maximum value (50 points). If only one question remains unanswered, the maximum value drops accordingly to 45 points and the score can be evaluated normally. The resulting score is then multiplied by 100 to provide a percentage which is referred to as the total score which ranges from 1 - 100%, with higher scores indicating a more severe disability.

Time frame
Baseline, 1 week, 6 weeks, 3 months, 6 months, 1 year
4

Roland Morris disability questionnaire (RMQ)

The RMQ is a 24-item patient-reported outcome measure that inquires about pain-related disability resulting from low back pain. Items are scored 0 if left blank or 1 if endorsed, for a total RMQ score ranging from 0 to 24; higher scores represent higher levels of pain-related disability.

Time frame
Baseline, 1 week, 6 weeks, 3 months, 6 months, 1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

R3 Stem Cell

Lead sponsor

R3 Medical Research

Collaborator