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Low Back PainPhase 1NCT06361485

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

A Phase 1 study testing Lumbar Injections with 10cc's of Wharton's Jelly Allograft in people with Low Back Pain, run by R3 Stem Cell at 4 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Low Back Pain
What is being tested?
Lumbar Injections with 10cc's of Wharton's Jelly Allograft
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
4 sitesUnited States
Study dates
25 Mar 2024to 1 Apr 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient must
  • 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).
  • Female participants must be abstinent, surgically sterilized or postmenopausal.
Show all 9Show fewer
  • 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.

Who cannot join

  • 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.
Show all 17Show fewer
  • 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.

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

David L Greene, MD, PhD, MBA contact

(602) 677-8981

dgreene@r3medicalresearch.com

Katherine Minter-Dykhouse, PhD contact

4803066256

kmd@bello.bio

United States4 sites, 4 recruiting

  • R3 Anti Aging Beverly Hills

    Beverly Hills, California, 90210

    Kathleen Francesca, BA, 424-382-1074, kfrancesca@r3stemcell.com

    Neville Campbell, MD

    Recruiting

  • Dr. Duc (Steve) Le, MD

    Cleveland, Texas, 77327

    Steve Le, MD, 281-593-1500, ducstevele@gmail.com

    Steve Le, MD

    Recruiting

  • Scheer Medical Wellness

    New York, New York, 10036

    Alexandre Scheer, MD, 646-762-9499, ascheer911@gmail.com

    Alexandre Scheer, MD

    Recruiting

  • R3 Anti Aging Scottsdale

    Scottsdale, Arizona, 85262

    David Greene, MD, PhD, MBA, 480-306-6256, dgreene@r3medicalresearch.com

    Sabrina Solt, NMD

    Recruiting

Other trials in United States

About this study

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.

Read the 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.

Conditions
Low Back Pain
Being tested
Lumbar Injections with 10cc's of Wharton's Jelly Allograft
Keywords
lumbago, low back pain, lumbar spondylosis, lumbar arthritis, facet syndrome, umbilical, umbilical cord allograft, stem cell, exosome
Medical subject headings
Low Back Pain, Spondylosis, Arthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    Also called BelloWJY

    Low Back Injections with Minimal Manipulation Umbilical Cord Tissue

Study groups in NCT06361485
Study groupRoleWhat they receive
Lumbar Injection ArmExperimentalLumbar Injections with 10cc's of Umbilical Cord Wharton's Jelly Allograft (BelloWJY)
Receives: Biological: Lumbar Injections with 10cc's of Wharton's Jelly Allograft

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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

    Measured: 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.

    Measured: 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

    Measured: Baseline, 1 week after the procedure, 6 weeks, 3 months, 6 months and one year

  5. Alkaline phosphatase (ALP)

    ALP is an enzyme important for breaking down proteins. Standard range: 40 to 129 units per liter

    Measured: Baseline, 1 week after the procedure, 6 weeks, 3 months, 6 months and one year

  6. Albumin

    Albumin is a protein made in the liver. Normal range is 34 to 54 grams/liter.

    Measured: Baseline, 1 week after the procedure, 6 weeks, 3 months, 6 months and one year

  7. 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

    Measured: Baseline, 1 week after the procedure, 6 weeks, 3 months, 6 months and one year

  8. Blood Urea Nitrogen (BUN)

    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.

    Measured: Baseline, 1 week after the procedure, 6 weeks, 3 months, 6 months and one year

Secondary outcomes (5)

  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.

    Measured: 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).

    Measured: 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.

    Measured: 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.

    Measured: Baseline, 1 week, 6 weeks, 3 months, 6 months, 1 year

  5. The Patient-specific functional scale (PSFS)

    This is a patient-specific questionnaire that requires patients to identify up to five important activities that they are having difficulty with as a result of their condition. The patient rates difficulty on an 11-point numerical scale (0 = unable to perform the activity; 10 = able to perform activity at the same level as before the injury or problem). The average score for up to five activities is established as the PSFS score. This scale has been established as reliable, valid, and responsive in a number of patient populations, including patients with low back pain. Higher scores indicate better functioning.

    Measured: Baseline, 1 week, 6 weeks, 3 months, 6 months, 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2024
  2. Study start25 Mar 2024
  3. Primary completion31 Mar 2027 (estimated)
  4. Study completion1 Apr 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Prospective, open label, non-controlled Pilot study
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06361485
Sponsor's protocol ID
011624
Status last verified
Apr 2024
First submitted
25 Mar 2024
Last updated
11 Apr 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Godoy-Brewer GM, Owodunni OP, Parian AM, Duraes LC, Selaru FM, Gearhart SL. Initial Clinical Outcomes Using Umbilical Cord-Derived Tissue Grafts to Repair Anovaginal Fistula. Dis Colon Rectum. 2023 Feb 1;66(2):299-305. doi: 10.1097/DCR.0000000000002258. Epub 2022 Jan 4.

    PubMed 35001050

  • Gibson JN, Grant IC, Waddell G. The Cochrane review of surgery for lumbar disc prolapse and degenerative lumbar spondylosis. Spine (Phila Pa 1976). 1999 Sep 1;24(17):1820-32. doi: 10.1097/00007632-199909010-00012.

    PubMed 10488513

  • Gibson JN, Waddell G. Surgery for degenerative lumbar spondylosis: updated Cochrane Review. Spine (Phila Pa 1976). 2005 Oct 15;30(20):2312-20. doi: 10.1097/01.brs.0000182315.88558.9c.

    PubMed 16227895

  • Deyo RA, Weinstein JN. Low back pain. N Engl J Med. 2001 Feb 1;344(5):363-70. doi: 10.1056/NEJM200102013440508. No abstract available.

    PubMed 11172169

  • Magora A, Schwartz A (1976) Relation between the low back pain syndrome and x-ray findings. I. Degenerative osteoarthritis. Scand J Rehab Med 8:115 - 125

  • Schmorl G, Junghanns H (1968) Die gesunde und die kranke Wirbelsäule in Röntgenbild und Klinik. Thieme, Stuttgart

  • Hanley EN Jr, David SM. Lumbar arthrodesis for the treatment of back pain. J Bone Joint Surg Am. 1999 May;81(5):716-30. doi: 10.2106/00004623-199905000-00015. No abstract available.

    PubMed 10360702

  • Fritzell P, Hagg O, Nordwall A; Swedish Lumbar Spine Study Group. Complications in lumbar fusion surgery for chronic low back pain: comparison of three surgical techniques used in a prospective randomized study. A report from the Swedish Lumbar Spine Study Group. Eur Spine J. 2003 Apr;12(2):178-89. doi: 10.1007/s00586-002-0493-8. Epub 2003 Feb 14.

    PubMed 12709856

  • Boswell MV, Colson JD, Sehgal N, Dunbar EE, Epter R. A systematic review of therapeutic facet joint interventions in chronic spinal pain. Pain Physician. 2007 Jan;10(1):229-53.

    PubMed 17256032

  • Gupta A, Maffulli N. Allogenic Umbilical Cord Tissue for Treatment of Knee Osteoarthritis. Sports Med Arthrosc Rev. 2022 Sep 1;30(3):162-165. doi: 10.1097/JSA.0000000000000350. Epub 2022 Aug 3.

    PubMed 35921598

  • Evaluation of the Efficacy of Cryopreserved Human Umbilical Cord Tissue Allografts to Augment Functional and Pain Outcome Measures in Patients with Knee Osteoarthritis: An Observational Data Collection Study, Davis et al, Physiologia 2022, 2(3), 109-120

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Lumbar Injections with 10cc's of Wharton's Jelly Allograft in people with Low Back Pain, run by R3 Stem Cell at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact David L Greene, MD, PhD, MBA ((602) 677-8981, dgreene@r3medicalresearch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

C-reactive protein (time frame: Baseline, 1 week after the procedure, 6 weeks, 3 months, 6 months and one year). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06361485, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2024.

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