Mesenchymal Stem Cells for Lumbar Degenerative Disc Disease

• Status: Not yet recruiting
• Trial end date: 2022-09-30
• Target enrollment: 0
• Participant gender: All

Summary

This study seeks to bridge these technologies and obtain data regarding the safety and efficacy of image guided percutaneous needle injection of expanded autologous bone marrow derived mesenchymal stem cells to symptomatic degenerated intervertebral discs in humans. The primary outcome will be to assess the safety and efficacy and monitor for adverse events.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Salim M Hayek
• Treatments: Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• Symptoms despite conservative (non-surgical) management for > 6 months

• Leg pain, if present, is of nonradicular origin, i.e., not due to stimulation of nerve roots or dorsal root ganglion of a spinal nerve by compressive forces.

• Leg pain, if present, does not extend below the knee and is no greater than 50% of low back pain as measured on a visual analog scale. If bilateral leg pain existed, the worst leg pain is no greater than 50% of low back pain.

• Diagnostic medical branch block or facet joint injection between 18 months and 2 weeks prior to the study procedure indicates no facet joint involvement.

• Distress and risk assessment method stratification to a) normal or b) at risk designations

• Modified Pfirrmann MR classification of implicated intervertebral discs of III, IV, or V

• Absence of infection

• Absence of coagulopathy

• Ability to provide informed written consent

Exclusion Criteria:

• Age > 80y or < 18 y

• Neoplasia

• History of recent or active malignancy(non-melanoma skin cancers, carcinoma in situ, etc. are allowable)

• Active infection

• Underlying congenital segmentation or other spinal anomalies that result in differential intervertebral disc pressures

• Significant spinal stenosis

• Interpreted as "severe" on any cross sectional imaging study

• Pregnant or planning to become pregnant

• Contraindication to MRI

• Indwelling medical devices such as pacemakers, aneurysm clips, etc

• Indwelling metal from any other cause (trauma, etc)

• To be excluded with history and radiographs, as necessary

• Immunosuppression

• History or laboratory results indicative of any significant cardiac, endocrine, hematologic, hepatic, immunologic, infectious, metabolic, urologic, pulmonary, gastrointestinal, dermatologic, psychiatric, renal, neoplastic, or other disorder that in the opinion of the Principal Investigator or his/her designee would preclude the safe performance of BM aspiration, transplantation of autologous MSCs, or performance of any of the planned study assessments.

• Uncorrectable coagulopathies

• Concurrent participation in another investigational trial involving systemic administration of agents or within the previous 30 days.

• Extreme obesity, as defined by NIH Clinical Guidelines Body Mass Index (BMI >35).

• Clinically relevant instability on flexion-extension as determined by the investigator by overlaying films.

• Have undergone a previous surgery at the involved level that may have altered the target disc (e.g. discectomy, laminectomy, foraminotomy, fusion, intradiscal electrothermal therapy, intradiscal radiofrequency thermocoagulation etc.).

• Have an acute fracture of the spine at the time of enrollment in the study. Clinically compromised vertebral bodies at the affected level due to current or past trauma, e.g., sustained pathological fracture or multiple fractures of vertebrae.

• Have a history of epidural steroid injections within 1 week prior to study treatment.

• Have received chronic (more than 7 consecutive days) treatment with systemic corticosteroids at a dose equivalent to prednisone ≥ 10 mg/day within 14 days prior to injection procedure.

• Have received systemic or local nonsteroidal anti-inflammatory drugs (NSAIDS) injections into the index and/or adjacent vertebral levels within 48 hours prior to study procedure.

• Have a known history of hypersensitivity or anaphylactic reaction to murine or bovine products or dimethyl sulfoxide (DMSO).

• Have a known history of hypersensitivity or anaphylactic reaction to products from birds, such as feathers, eggs or poultry.

• Have a positive screen for human immunodeficiency virus (HIV) by antibodies or nucleic acid test.

• Have had treatment with any investigational therapy or device within 6 months of study procedure and/or plans to participate in any other allogeneic stem cell/progenitor cell therapy trial during the 3-year follow-up period.

• Have been a recipient of prior stem cell/progenitor cell therapy or other biological intervention to repair the target intervertebral disc.

• 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.

• Habitual use of tobacco throughout the trial and follow-up.

• Have a mental illness that could prevent completion of the study or protocol questionnaires. If subjects with psychiatric disease are stable, then they should be allowed to participate in the trial.

• Neurological diseases including unstable diseases or disease which renders subjects unable to give informed consent which renders unable to give informed consent. (Subjects with well controlled epilepsy should not be excluded.)