Is NCT04042844 recruiting in Walnut Creek, CA?

Yes, NCT04042844 is currently recruiting participants at its Walnut Creek, CA location. This chronic lumbar disc disease clinical trial is actively enrolling qualified participants.

How do I join the chronic lumbar disc disease clinical trial in Walnut Creek?

To join this clinical trial in Walnut Creek, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Walnut Creek clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Chronic Lumbar Disc Disease Clinical Trial in Walnut Creek, CA

About This Chronic Lumbar Disc Disease Study in Walnut Creek

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,

Sponsor: BioRestorative Therapies

Who Can Participate

Inclusion Criteria

A subject is eligible for inclusion if all the following criteria are met:

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)

Chronic Lower Back Pain for at least 6 months

Pain commonly provoked by prolonged sitting, forward bending, lifting, twisting, coughing, sneezing, or Valsalva maneuvers

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)

Failure of supervised therapy (such as physical therapy)

Screening of ≥ 40 mm and ≤ 80 mm on low back pain visual analog scales (VAS) (average pain in the last week)

Screening Oswestry Disability Index (ODI) score ≥ 30 and \< 90 on a 100-point scale

No localized and significant pain below beltline (i.e., potential sacroiliac joint pain) without lumbar pain component

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

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

Has degenerative disc disease (DDD) as defined by the following:

Changes from normal disc morphology of the affected disc as defined by radiographic evaluation

Modified Pfirrmann score of 2 to 7 on MRI, may contain a contained protrusion and/or annular tear on MRI

Modified Pfirrmann score of 1 must contain a contained protrusion and/or annular tear on MRI

Modic Grade I or II changes or no change on MRI

Maintained intervertebral disc heights of at least 50% on MRI.

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

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

Aged ≥18 years of age at the time of consent

Willing and able to provide written informed consent

No evidence of contraindications to the procedure such as pregnancy, active infection, bleeding disorder, or metastatic cancer Subject

Exclusion Criteria

A subject is not eligible to participate if any of the following criteria are met:

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

Disc extrusions, sequestered fragments, facet cysts, or greater than moderate spinal stenosis on MRI.

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

Intervertebral disc with radiographic evidence of Modified Pfirrmann Grade 8 or greater

Any bleeding disorder, intrinsic or extrinsic

Required anticoagulation (with either antiplatelet agents or antithrombotics) that cannot be interrupted for harvest and injection procedures

Platelet count less than or equal to 100,000

International Normalized Ratio (INR) greater than or equal to 1.5

Extreme obesity, as defined by NIH Clinical Guidelines Body Mass Index (BMI greater than or equal to 40)

Clinically relevant instability on flexion-extension as determined by the investigator by overlaying films (flexion \& extension films)

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

Have any acute or chronic lumbosacral spine fracture

Have a history of lumbosacral epidural steroid injections within 1 month prior to informed consent date.

Planned/expected use of systemic nonsteroidal anti-inflammatory drugs (NSAIDs) within 72 hours prior to study treatment.

Have a known history of hypersensitivity or anaphylactic reaction to dimethyl sulfoxide (DMSO)

Active significant non lumbosacral spinal orthopedic pain generators including, not limited to arthritic hip and/or knee, cervical disc disease

More widespread and ill-defined myofascial pain

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

Have been a recipient of any lumbosacral intervertebral disc injection for therapeutic purposes

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

Apparent ongoing and poorly controlled psychological or somatic disease that may impact treatment outcomes

Social, familial, or geographical hindrances to compliance with the study protocol or the informed consent process

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)

Required chronic immunosuppression

Positive hepatitis C virus (HCV) antibody test

Positive human immunodeficiency virus (HIV) Antigen/Antibody (Ag/Ab) Combo test

Pregnant or lactating women

Women of childbearing potential not protected by a highly effective method of birth control. Highly effective methods of contraception \[defined as those, alone or in combination, that result in a low (\<1%) failure rate\] include, but are not limited to, combined (estrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation (either oral, intravaginal, transdermal or injectable), progestogen-only hormonal contraception associated with inhibition of ovulation (either oral, injectable or implantable), intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomized partner, sexual abstinence, or a double-barrier method (i.e., male condom combined with diaphragm with spermicide). The investigator is responsible for review of medical history, contraception history, menstrual history and recent sexual activity to decrease the risk of including a woman with an undetected early pregnancy. Additionally, the investigator is responsible for determining if, in the investigator's judgment, a woman's planned contraceptive method (including an assessment of her reliability for consistent use of this method) meets the protocol requirement of "highly effective."

Hematology and chemistry values including, but not limited to:

Total bilirubin level 1.5 times institutional upper limit of normal (ULN)

Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) 2 x ULN

Absolute neutrophil count (ANC) \< 1000/mm3

Hemoglobin less than or equal to 10 g/dL

Creatinine clearance use calculated clearance (Cockcroft-Gault equation) of less than or equal to 50 mL/min

Other labs deemed clinically significant which, in the opinion of the investigator, might influence the subject's health or safety during the trial.

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

Inability to comply with the requirements of the study protocol

Actively on workers compensation or no-fault case for this complaint or any other active case or litigation pertaining to their lumbosacral pain.

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.

History of regular, long term, daily opioid drug use (greater than or equal to 30 MME)

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Walnut Creek?

Yes, this clinical trial (NCT04042844) has an active research site in Walnut Creek, CA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Chronic Lumbar Disc Disease Treatment Options in Walnut Creek, CA

If you're searching for chronic lumbar disc disease treatment options in Walnut Creek, CA, this clinical trial (NCT04042844) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Walnut Creek research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced chronic lumbar disc disease specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all chronic lumbar disc disease clinical trials near you to find additional studies recruiting in your area.

Chronic Lumbar Disc Disease Clinical Trial in Walnut Creek, CA

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