RECRUITING

A Single Dose of BRTX 100 for Patients With Chronic Lumbar Disc Disease (cLDD)

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a double-blind, controlled, randomized study with blinded assessments using a single dose. Subjects that have a current diagnosis of chronic lumbar disc disease and meet eligibility criteria will be enrolled. Chronic lumbar disc disease is defined as back and/or radicular pain with degeneration of the disc confirmed by patient history, physical examination, and radiographic measures such as computed tomography (CT), magnetic resonance imaging (MRI), plain film, myelography, discography, or other acceptable means.

Official Title

A Phase 2, Double-Blind, Controlled, Randomized Study to Evaluate the Safety and Preliminary Efficacy of a Single Dose Intradiscal Injection of BRTX-100 for Patients With Chronic Lumbar Disc Disease (cLDD)

Quick Facts

Study Start:2022-06-30

Study Completion:2027-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04042844

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. A high index of suspicion for discogenic pain, (i.e., painful degenerative disc(s) with or without protrusions less than or equal to 5 mm) 1. Chronic Lower Back Pain for at least 6 months 2. Pain commonly provoked by prolonged sitting, forward bending, lifting, twisting, coughing, sneezing, or Valsalva maneuvers 3. Failure of at least 6 months of conservative back pain care (can include any or all of the following: rest, anti-inflammatory medication, analgesics, narcotics, epidural injections or selective nerve root injections at the target level, facet joint injections, muscle relaxers, massage, acupuncture, chiropractic care) 4. Failure of supervised therapy (such as physical therapy) 5. Screening of ≥ 40 mm and ≤ 80 mm on low back pain visual analog scales (VAS) (average pain in the last week) 6. Screening Oswestry Disability Index (ODI) score ≥ 30 and \< 90 on a 100-point scale 7. No localized and significant pain below beltline (i.e., potential sacroiliac joint pain) without lumbar pain component 8. Thigh or Leg pain, if present, is non prevailing and of nonradicular origin, i.e., not due to stimulation of nerve roots or dorsal root ganglion of a spinal nerve by compressive forces 9. Diagnostic medial branch block or facet joint injection (bilateral unless the symptoms are purely unilateral in nature) in the last 12 months prior to the informed consent date indicates no prevailing facet joint involvement 2. Has degenerative disc disease (DDD) as defined by the following: 1. Changes from normal disc morphology of the affected disc as defined by radiographic evaluation 2. Modified Pfirrmann score of 2 to 7 on MRI, may contain a contained protrusion and/or annular tear on MRI 3. Modified Pfirrmann score of 1 must contain a contained protrusion and/or annular tear on MRI 4. Modic Grade I or II changes or no change on MRI 5. Maintained intervertebral disc heights of at least 50% on MRI. 6. Discography, if not performed within the last 6 months prior to informed consent date, has to be performed if more than one degenerative disc is identified by MRI, and the symptomatic disc cannot be otherwise reasonably determined 7. If more than one degenerative disc is identified by MRI, no disc shall demonstrate greater degenerative change than the symptomatic disc or contain a protrusion greater than 5mm 3. Aged ≥18 years of age at the time of consent 4. Willing and able to provide written informed consent 5. No evidence of contraindications to the procedure such as pregnancy, active infection, bleeding disorder, or metastatic cancer	1. Spinal Deformity (Scoliosis greater than or equal to 20 degrees, spondylolysis, clinically or radiographically significant retrolisthesis or spondylolisthesis) detected on MRI or plain film radiographic assessment 2. Disc extrusions, sequestered fragments, facet cysts, or greater than moderate spinal stenosis on MRI. 3. Presence of a Grade V annular fissure observed within the index disc level during discography in a subject for whom provocation discography has been performed 4. Intervertebral disc with radiographic evidence of Modified Pfirrmann Grade 8 or greater 5. Any bleeding disorder, intrinsic or extrinsic 6. Required anticoagulation (with either antiplatelet agents or antithrombotics) that cannot be interrupted for harvest and injection procedures 7. Platelet count less than or equal to 100,000 8. International Normalized Ratio (INR) greater than or equal to 1.5 9. Extreme obesity, as defined by NIH Clinical Guidelines Body Mass Index (BMI greater than or equal to 40) 10. Clinically relevant instability on flexion-extension as determined by the investigator by overlaying films (flexion \& extension films) 11. Has undergone any previous lumbosacral spine surgery (e.g. discectomy, laminectomy, foraminotomy, fusion, intradiscal electrothermal therapy, intradiscal radiofrequency thermocoagulation.), ablation of lumbar basiverterbral nerve or therapeutic percutaneous disc intervention 12. Have any acute or chronic lumbosacral spine fracture 13. Have a history of lumbosacral epidural steroid injections within 1 month prior to informed consent date. 14. Planned/expected use of systemic nonsteroidal anti-inflammatory drugs (NSAIDs) within 72 hours prior to study treatment. 15. Have a known history of hypersensitivity or anaphylactic reaction to dimethyl sulfoxide (DMSO) 16. Active significant non lumbosacral spinal orthopedic pain generators including, not limited to arthritic hip and/or knee, cervical disc disease 17. More widespread and ill-defined myofascial pain 18. Have had treatment with any cellular or biological investigational therapy or device within 6 months of informed consent date and/or plans to participate in any other autologous or allogeneic stem cell/progenitor cell therapy trial during the 2 year follow-up period 19. Have been a recipient of any lumbosacral intervertebral disc injection for therapeutic purposes 20. Are transient or has been treated in the last 6 months before enrollment for alcohol and/or drug abuse in an inpatient substance abuse program 21. Apparent ongoing and poorly controlled psychological or somatic disease that may impact treatment outcomes 22. Social, familial, or geographical hindrances to compliance with the study protocol or the informed consent process 23. Known autoimmune disease with primary impact on the musculoskeletal and/or neurological systems (e.g., systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren's syndrome, myasthenia gravis, polymyositis/dermatomyositis, Guillain-Barre syndrome, autoimmune vasculitis) 24. Required chronic immunosuppression 25. Positive hepatitis C virus (HCV) antibody test 26. Positive human immunodeficiency virus (HIV) Antigen/Antibody (Ag/Ab) Combo test 27. Pregnant or lactating women 28. Women of childbearing potential not protected by a highly effective method of birth control. 29. Hematology and chemistry values including, but not limited to: 1. Total bilirubin level 1.5 times institutional upper limit of normal (ULN) 2. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) 2 x ULN 3. Absolute neutrophil count (ANC) \< 1000/mm3 4. Hemoglobin less than or equal to 10 g/dL 5. Creatinine clearance use calculated clearance (Cockcroft-Gault equation) of less than or equal to 50 mL/min 6. Other labs deemed clinically significant which, in the opinion of the investigator, might influence the subject's health or safety during the trial. 30. Have any other active medical conditions, medical or psychiatric illness which, in the opinion of the Investigator, would preclude adequate evaluation of the safety and efficacy of the study or put the participant at risk 31. Inability to comply with the requirements of the study protocol 32. Actively on workers compensation or no-fault case for this complaint or any other active case or litigation pertaining to their lumbosacral pain. 33. History of drug or alcohol abuse or documented history of noncompliance with controlled substances that, in the investigator's opinion, could interfere with adequate evaluation of the study drug's safety or efficacy or otherwise make the subject unsuitable for the study. 34. History of regular, long term, daily opioid drug use (greater than or equal to 30 MME)

Inclusion Criteria

Exclusion Criteria

1. A high index of suspicion for discogenic pain, (i.e., painful degenerative disc(s) with or without protrusions less than or equal to 5 mm)
1. Chronic Lower Back Pain for at least 6 months
2. Pain commonly provoked by prolonged sitting, forward bending, lifting, twisting, coughing, sneezing, or Valsalva maneuvers
3. Failure of at least 6 months of conservative back pain care (can include any or all of the following: rest, anti-inflammatory medication, analgesics, narcotics, epidural injections or selective nerve root injections at the target level, facet joint injections, muscle relaxers, massage, acupuncture, chiropractic care)
4. Failure of supervised therapy (such as physical therapy)
5. Screening of ≥ 40 mm and ≤ 80 mm on low back pain visual analog scales (VAS) (average pain in the last week)
6. Screening Oswestry Disability Index (ODI) score ≥ 30 and \< 90 on a 100-point scale
7. No localized and significant pain below beltline (i.e., potential sacroiliac joint pain) without lumbar pain component
8. Thigh or Leg pain, if present, is non prevailing and of nonradicular origin, i.e., not due to stimulation of nerve roots or dorsal root ganglion of a spinal nerve by compressive forces
9. Diagnostic medial branch block or facet joint injection (bilateral unless the symptoms are purely unilateral in nature) in the last 12 months prior to the informed consent date indicates no prevailing facet joint involvement
2. Has degenerative disc disease (DDD) as defined by the following:
1. Changes from normal disc morphology of the affected disc as defined by radiographic evaluation
2. Modified Pfirrmann score of 2 to 7 on MRI, may contain a contained protrusion and/or annular tear on MRI
3. Modified Pfirrmann score of 1 must contain a contained protrusion and/or annular tear on MRI
4. Modic Grade I or II changes or no change on MRI
5. Maintained intervertebral disc heights of at least 50% on MRI.
6. Discography, if not performed within the last 6 months prior to informed consent date, has to be performed if more than one degenerative disc is identified by MRI, and the symptomatic disc cannot be otherwise reasonably determined
7. If more than one degenerative disc is identified by MRI, no disc shall demonstrate greater degenerative change than the symptomatic disc or contain a protrusion greater than 5mm
3. Aged ≥18 years of age at the time of consent
4. Willing and able to provide written informed consent
5. No evidence of contraindications to the procedure such as pregnancy, active infection, bleeding disorder, or metastatic cancer

1. Spinal Deformity (Scoliosis greater than or equal to 20 degrees, spondylolysis, clinically or radiographically significant retrolisthesis or spondylolisthesis) detected on MRI or plain film radiographic assessment
2. Disc extrusions, sequestered fragments, facet cysts, or greater than moderate spinal stenosis on MRI.
3. Presence of a Grade V annular fissure observed within the index disc level during discography in a subject for whom provocation discography has been performed
4. Intervertebral disc with radiographic evidence of Modified Pfirrmann Grade 8 or greater
5. Any bleeding disorder, intrinsic or extrinsic
6. Required anticoagulation (with either antiplatelet agents or antithrombotics) that cannot be interrupted for harvest and injection procedures
7. Platelet count less than or equal to 100,000
8. International Normalized Ratio (INR) greater than or equal to 1.5
9. Extreme obesity, as defined by NIH Clinical Guidelines Body Mass Index (BMI greater than or equal to 40)
10. Clinically relevant instability on flexion-extension as determined by the investigator by overlaying films (flexion \& extension films)
11. Has undergone any previous lumbosacral spine surgery (e.g. discectomy, laminectomy, foraminotomy, fusion, intradiscal electrothermal therapy, intradiscal radiofrequency thermocoagulation.), ablation of lumbar basiverterbral nerve or therapeutic percutaneous disc intervention
12. Have any acute or chronic lumbosacral spine fracture
13. Have a history of lumbosacral epidural steroid injections within 1 month prior to informed consent date.
14. Planned/expected use of systemic nonsteroidal anti-inflammatory drugs (NSAIDs) within 72 hours prior to study treatment.
15. Have a known history of hypersensitivity or anaphylactic reaction to dimethyl sulfoxide (DMSO)
16. Active significant non lumbosacral spinal orthopedic pain generators including, not limited to arthritic hip and/or knee, cervical disc disease
17. More widespread and ill-defined myofascial pain
18. Have had treatment with any cellular or biological investigational therapy or device within 6 months of informed consent date and/or plans to participate in any other autologous or allogeneic stem cell/progenitor cell therapy trial during the 2 year follow-up period
19. Have been a recipient of any lumbosacral intervertebral disc injection for therapeutic purposes
20. Are transient or has been treated in the last 6 months before enrollment for alcohol and/or drug abuse in an inpatient substance abuse program
21. Apparent ongoing and poorly controlled psychological or somatic disease that may impact treatment outcomes
22. Social, familial, or geographical hindrances to compliance with the study protocol or the informed consent process
23. Known autoimmune disease with primary impact on the musculoskeletal and/or neurological systems (e.g., systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren's syndrome, myasthenia gravis, polymyositis/dermatomyositis, Guillain-Barre syndrome, autoimmune vasculitis)
24. Required chronic immunosuppression
25. Positive hepatitis C virus (HCV) antibody test
26. Positive human immunodeficiency virus (HIV) Antigen/Antibody (Ag/Ab) Combo test
27. Pregnant or lactating women
28. Women of childbearing potential not protected by a highly effective method of birth control.
29. Hematology and chemistry values including, but not limited to:
1. Total bilirubin level 1.5 times institutional upper limit of normal (ULN)
2. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) 2 x ULN
3. Absolute neutrophil count (ANC) \< 1000/mm3
4. Hemoglobin less than or equal to 10 g/dL
5. Creatinine clearance use calculated clearance (Cockcroft-Gault equation) of less than or equal to 50 mL/min
6. Other labs deemed clinically significant which, in the opinion of the investigator, might influence the subject's health or safety during the trial.
30. Have any other active medical conditions, medical or psychiatric illness which, in the opinion of the Investigator, would preclude adequate evaluation of the safety and efficacy of the study or put the participant at risk
31. Inability to comply with the requirements of the study protocol
32. Actively on workers compensation or no-fault case for this complaint or any other active case or litigation pertaining to their lumbosacral pain.
33. History of drug or alcohol abuse or documented history of noncompliance with controlled substances that, in the investigator's opinion, could interfere with adequate evaluation of the study drug's safety or efficacy or otherwise make the subject unsuitable for the study.
34. History of regular, long term, daily opioid drug use (greater than or equal to 30 MME)

Contacts and Locations

Study Contact

Francisco Silva

CONTACT

1(949)394-0132

FSilva@biorestorative.com

Principal Investigator

Jason Lipitz, MD

STUDY_CHAIR

BioRestorative Therapies

Study Locations (Sites)

Alabama Clinical Therapeutics, LLC

Birmingham, Alabama, 35235

United States

Source Healthcare

Santa Monica, California, 90403

United States

Boomerang Healthcare

Walnut Creek, California, 94598

United States

Denver Back Pain Specialists, LLC

Greenwood Village, Colorado, 80111

United States

Cantor Spine Institute

Fort Lauderdale, Florida, 33306

United States

Coastal Health

Jacksonville, Florida, 32257

United States

Pain Relief Centers

St. Petersburg, Florida, 33709

United States

Tampa Pain Relief Center

Tampa, Florida, 33603

United States

Florida Pain Relief Center

Tampa, Florida, 33614

United States

Conquest Research

Winter Park, Florida, 32789

United States

Northwell Health

New York, New York, 10022

United States

The Center of Clinical Research, LLC

Winston-Salem, North Carolina, 27103

United States

Cleveland Clinic

Cleveland, Ohio, 44195

United States

Clinical Investigations LLC

Edmond, Oklahoma, 73013

United States

Coastal Carolina Research Center

North Charleston, South Carolina, 29406,

United States

Science Connections

Austin, Texas, 78758

United States

NCP Center for Clinical Research and Innovation

Houston, Texas, 77008

United States

Precision Spine Care

Tyler, Texas, 75701

United States

Virginia iSpine Physicians

Richmond, Virginia, 23235

United States

Collaborators and Investigators

Sponsor: BioRestorative Therapies

Jason Lipitz, MD, STUDY_CHAIR, BioRestorative Therapies

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-06-30

Study Completion Date2027-12

Study Record Updates

Study Start Date2022-06-30

Study Completion Date2027-12

Terms related to this study

Additional Relevant MeSH Terms

Lumbar Disc Disease