Mesenchymal Stem Cells for Lumbar Degenerative Disc Disease

NCT03692221 | Withdrawn Early Phase 1 DMC FDA Drug

• 1 other identifier: 014924/0012/A002
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Disc Degeneration

Keywords

Back pain

Outcome Measures

Primary Outcomes (1)

• Rate of treatment related adverse events

  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. .

  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.

Secondary Outcomes (4)

• Changes in Pain -Visual Analogue Scale (VAS) for back pain

  Baseline, 1 month, 6 months and 1 year

• Changes in Pain - Oswestry Disability Index (ODI) scores over time

  Baseline, 1 month, 6 months and 1 year

• changes in Quality of life - Short form Health Survey 36 (SF-36)

  Baseline, 1 month, 6 months and 1 year

• changes in MRI monitoring of transplant site

  Baseline and 1 year, if a subject were to withdraw prior to completion of the study and received MSC an MRI with be obtained.

Study Arms (3)

MSC treatment group 1

EXPERIMENTAL

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)

MSC treatment group 2

ACTIVE COMPARATOR

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)

Healthy Control (no treatment)

ACTIVE COMPARATOR

Comparative analysis of psychometric and morphometric based data

Other: Healthy Control (no treatment)

Interventions

MSC Treatment group 1 (low dose) DRUG

Autologous Bone Marrow Derived Mesenchymal Stem Cells (MSC) - A one time injection of 1-2 ml of a 4 x 106/ml concentration solution

MSC treatment group 1

MSC Treatment group 2 (high dose) DRUG

Autologous Bone Marrow Derived Mesenchymal Stem Cells (MSC) - A one time injection of 1-2 ml of a 4 x 106/ml concentration solution

MSC treatment group 2

Healthy Control (no treatment) OTHER

Comparative analysis of psychometric and morphometric based data

Healthy Control (no treatment)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead

Study Sites (1)

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

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Related Links

• Mesoblast, I. United States FDA clears Mesoblast phase 2 trial to treat degenerative disc disease. 2011;

MeSH Terms

Conditions

Intervertebral Disc Degeneration; Back Pain

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Melinda Lawrence, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Chief, Division of Pain Medicine

Model Details: 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

Study Record Dates

• First Submitted: September 24, 2018
• First Posted: October 2, 2018
• Study Start: June 1, 2019
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2022
• Last Updated: May 5, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)