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Mesenchymal Stem Cells for Lumbar Degenerative Disc Disease

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ClinicalTrials.gov Identifier: NCT03692221
Recruitment Status : Not yet recruiting
First Posted : October 2, 2018
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
Salim M Hayek, University Hospitals Cleveland Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Disc Degeneration Drug: MSC Treatment group 1 (low dose) Drug: MSC Treatment group 2 (high dose) Other: Healthy Control (no treatment) Early Phase 1

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 24 participants will be equally randomized into two groups; 12 Healthy controls subjects & 12 treatment subjects. The treatment group will then be sub-divided and randomized into 6 subjects receiving a low dosage treatment and 6 subjects receiving a high dosage treatment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Percutaneous Image Guided Delivery of Autologous Bone Marrow Derived Mesenchymal Stem Cells for the Treatment of Symptomatic Degenerated Intervertebral Disc Disease
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : September 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MSC treatment group 1
Low dose of Autologous Bone Marrow Derived Mesenchymal Stem Cells (MSC) -A one time injection of 1-2 ml of 2 x 106/ml concentrated solution
Drug: MSC Treatment group 1 (low dose)
Autologous Bone Marrow Derived Mesenchymal Stem Cells (MSC) - A one time injection of 1-2 ml of a 4 x 106/ml concentration solution

Active Comparator: MSC treatment group 2
High dose of Autologous Bone Marrow Derived Mesenchymal Stem Cells (MSC) -A one time injection of 1-2 ml of 4 x 106/ml concentrated solution
Drug: MSC Treatment group 2 (high dose)
Autologous Bone Marrow Derived Mesenchymal Stem Cells (MSC) - A one time injection of 1-2 ml of a 4 x 106/ml concentration solution

Active Comparator: Healthy Control (no treatment)
Comparative analysis of psychometric and morphometric based data
Other: Healthy Control (no treatment)
Comparative analysis of psychometric and morphometric based data




Primary Outcome Measures :
  1. Rate of treatment related adverse events [ Time Frame: From baseline/randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year. ]
    assessing for worsening of patients' baseline symptoms or functions (will be considered an AE); (also general AE events), particularly AE events related to the procedures/treatment. All AEs will be assessed by common terminology criteria for adverse events. .


Secondary Outcome Measures :
  1. Changes in Pain -Visual Analogue Scale (VAS) for back pain [ Time Frame: Baseline, 1 month, 6 months and 1 year ]

    Temporal evaluation of pain before and after the procedure will be analyzed through documentation of Visual Analogue Scale of back pain (VAS).

    The VAS is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. It is a unidimensional measure of pain intensity The instrument is presented by a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (symptom, pain, health) orientated from the left (worst) to the right (best). Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. No pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm) (11).


  2. Changes in Pain - Oswestry Disability Index (ODI) scores over time [ Time Frame: Baseline, 1 month, 6 months and 1 year ]
    Temporal evaluation of pain before and after the procedure will be analyzed through documentation of Oswestry Disability Index (ODI) scores over time. Scoring - For each section the total possible score is 5: if the first statement is marked the section score = 0; if the last statement is marked, it = 5. If all 10 sections are completed the score is calculated. Interpretation scores go from minimal 0% disability to 100% disability.

  3. changes in Quality of life - Short form Health Survey 36 (SF-36) [ Time Frame: Baseline, 1 month, 6 months and 1 year ]
    Temporal evaluation of quality of life before and after the procedure will be analyzed through documentation of SF36 quality of life questionnaire scores. Although this study is not cancer related, this questionnaire is a validated instrument for the evaluation of treatment related impact on quality of life - a critical outcome measure. Scoring - consisting of eight scaled scores which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.

  4. changes in MRI monitoring of transplant site [ Time Frame: Baseline and 1 year, if a subject were to withdraw prior to completion of the study and received MSC an MRI with be obtained. ]
    Magnetic resonance T2 mapping will be performed on all discs undergoing treatment for evaluation of potential quantitative, reproducible imaging change following treatment.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03692221


Contacts
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Contact: Mario A Becerra, RN, BA 216) 844-1734 Mario.Becerra@UHhospitals.org

Locations
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United States, Ohio
University Hospitals Cleveland Medical Center Not yet recruiting
Cleveland, Ohio, United States, 44106
Contact: Mario A Becerra, RN, BA    216-844-1734    Mario.Becerra@UHhospitals.org   
Principal Investigator: Melinda Lawrence, MD         
Sub-Investigator: Salim Hayek, MD         
Sub-Investigator: Zhenghong Lee, PhD         
Sub-Investigator: Ameya Nayate, MD         
Sub-Investigator: Jane Reese-Koc, BA, MBA         
Sub-Investigator: Sidhartha Tavri, MD         
Sub-Investigator: Elias Veizi, MD, PhD         
Sponsors and Collaborators
Salim M Hayek
Investigators
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Principal Investigator: Melinda Lawrence, MD University Hospitals Cleveland Medical Center

Additional Information:
Publications:
Williams JD, P.K., ed. Lower Back Pain and Disorders of Intervertebral Discs. 11 ed. Campbell's Operative Orthopaedics., ed. C.a. Beaty. 2007, Mosby.
Recommendations of the International Conference on Harmonization. . in Fed Regist. 1997.
Julious SA, Sample size of 12 per group rule of thumb for a pilot study. Pharmaceutical Statistics. 2005 4:287-291. doi:1 0.1002/pst.185.

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Responsible Party: Salim M Hayek, MD, PhD, Chief, Division of Pain Medicine, University Hospitals Cleveland Medical Center
ClinicalTrials.gov Identifier: NCT03692221     History of Changes
Other Study ID Numbers: 014924/0012/A002
First Posted: October 2, 2018    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Salim M Hayek, University Hospitals Cleveland Medical Center:
Back pain
Additional relevant MeSH terms:
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Intervertebral Disc Degeneration
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Pharmaceutical Solutions