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

NCT06361485 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: 011624
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 4

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.

Conditions

Low Back Pain

Keywords

lumbago; low back pain; lumbar spondylosis; lumbar arthritis; facet syndrome; umbilical; umbilical cord allograft; stem cell; exosome

Outcome Measures

Primary Outcomes (8)

• 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.

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

• 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

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

• 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.

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

• Aspartate transaminase (AST)

  AST is an enzyme that helps the body break down amino acids. . Standard range: AST 8 to 48 units per liter

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

• Alkaline phosphatase (ALP)

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

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

• Albumin

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

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

• 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

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

• 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.

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

Secondary Outcomes (5)

• 36-Item Short Form Survey (SF-36)

  Baseline, 24 hours after intervention, 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

• 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

• The Patient-specific functional scale (PSFS)

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

Study Arms (1)

Lumbar Injection Arm

EXPERIMENTAL

Lumbar Injections with 10cc's of Umbilical Cord Wharton's Jelly Allograft (BelloWJY)

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

Interventions

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

Low Back Injections with Minimal Manipulation Umbilical Cord Tissue

Also known as: BelloWJY

Lumbar Injection Arm

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• R3 Stem Cell: lead
• R3 Medical Research: collaborator

Study Sites (4)

R3 Anti Aging Scottsdale

Scottsdale, Arizona, 85262, United States

RECRUITING

R3 Anti Aging Beverly Hills

Beverly Hills, California, 90210, United States

RECRUITING

Scheer Medical Wellness

New York, New York, 10036, United States

RECRUITING

Dr. Duc (Steve) Le, MD

Cleveland, Texas, 77327, United States

RECRUITING

Related Publications (11)

• 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.

  PMID: 35001050 BACKGROUND

• 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.

  PMID: 10488513 RESULT

• 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.

  PMID: 16227895 RESULT

• 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.

  PMID: 11172169 RESULT

• 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

  RESULT

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

  RESULT

• 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.

  PMID: 10360702 RESULT

• 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.

  PMID: 12709856 RESULT

• 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.

  PMID: 17256032 RESULT

• 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.

  PMID: 35921598 RESULT

• 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

  RESULT

MeSH Terms

Conditions

Low Back Pain; Spondylosis; Arthritis

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Joint Diseases

Study Officials

• James Faber, BA

  Institute of Cellular and Regenerative Medicine IRB

  STUDY CHAIR

Central Study Contacts

David L Greene, MD, PhD, MBA

CONTACT

(602) 677-8981; dgreene@r3medicalresearch.com

Katherine Minter-Dykhouse, PhD

CONTACT

4803066256; kmd@bello.bio

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: Open Label
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, open label, non-controlled Pilot study

Study Record Dates

• First Submitted: March 25, 2024
• First Posted: April 11, 2024
• Study Start: March 25, 2024
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: April 11, 2024

Record last verified: 2024-04

Locations

US (4)