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

Overview

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.

Interventions

• Biological Lumbar Injections with 10cc's of Wharton's Jelly Allograft
  Low Back Injections with Minimal Manipulation Umbilical Cord Tissue

Primary outcome measures

• C-reactive protein [Time frame: Baseline, 1 week after the procedure, 6 weeks, 3 months, 6 months and one year]
• Erythrocyte sedimentation rate [Time frame: Baseline, 1 week after the procedure, 6 weeks, 3 months, 6 months and one year]
• Alanine transaminase (ALT) [Time frame: Baseline, 1 week after the procedure, 6 weeks, 3 months, 6 months and one year]
• Aspartate transaminase (AST) [Time frame: Baseline, 1 week after the procedure, 6 weeks, 3 months, 6 months and one year]
• Alkaline phosphatase (ALP) [Time frame: Baseline, 1 week after the procedure, 6 weeks, 3 months, 6 months and one year]
• Albumin [Time frame: Baseline, 1 week after the procedure, 6 weeks, 3 months, 6 months and one year]
• Creatinine [Time frame: Baseline, 1 week after the procedure, 6 weeks, 3 months, 6 months and one year]
• Blood Urea Nitrogen (BUN) [Time frame: Baseline, 1 week after the procedure, 6 weeks, 3 months, 6 months and one year]

Secondary outcome measures (5)

• 36-Item Short Form Survey (SF-36) [Time frame: Baseline, 24 hours after intervention, 1 week, 6 weeks, 3 months, 6 months, 1 year]
• Numerical Pain Rating Scale (NPRS) [Time frame: Baseline, 24 hours after intervention, 1 week, 6 weeks, 3 months, 6 months, 1 year]
• Oswestry disability index (ODI) [Time frame: Baseline, 1 week, 6 weeks, 3 months, 6 months, 1 year]
• Roland Morris disability questionnaire (RMQ) [Time frame: Baseline, 1 week, 6 weeks, 3 months, 6 months, 1 year]
• The Patient-specific functional scale (PSFS) [Time frame: Baseline, 1 week, 6 weeks, 3 months, 6 months, 1 year]

Eligibility criteria

Inclusion criteria

• 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.

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 4 centers

• R3 Anti Aging Scottsdale — Scottsdale
• R3 Anti Aging Beverly Hills — Beverly Hills
• Scheer Medical Wellness — New York
• Dr. Duc (Steve) Le, MD — Cleveland

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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 12709856

Identifiers

NCT: NCT06361485 · 011624

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗