Allogeneic Human Mesenchymal Stem Cell Injection in PAtieNts With FaceTogenic Back Pain

NCT03487731 | Withdrawn Phase 1 DMC FDA Drug

• 1 other identifier: 20180018
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The study is a phase I/II trial where allogeneic human mesenchymal stem cells (hMSCs) are injected intracfect into the lumbar facet joints. Forty (40) subjects are scheduled to undergo injection after meeting all inclusion/exclusion criteria will be evaluate at baseline.

Conditions

Facetogenic Back Pain; Back Pain

Keywords

stem cells; back pain

Outcome Measures

Primary Outcomes (1)

• Incidence of any treatment-emergent serious adverse events

  Incidence (at one-month post injection) of any treatment-emergent serious adverse events.

  at one-month post injection

Secondary Outcomes (4)

• Difference in subject quality of life assessment - SF-12

  Baseline, Month 3, and Month 6

• Difference in subject quality of life assessment - Oswestry Low Back Pain

  Baseline, Month 3, and Month 6

• Death from any cause.

  Baseline, Month 3, and Month 6

• Change in pain using the Numeric rating scale

  Baseline and Month 6

Study Arms (4)

Group 1 - Placebo

PLACEBO COMPARATOR

Group 1 - Five (5) subjects will be treated with a single administration of 1 cc of 1% lidocaine with 1 cc of 2% Ropivicaine and 0.5 cc of betamethasone soluspan (celestone) solution delivered via intra-facet injection. These subjects will be part of the control (Standard care) group.

Drug: Placebo

Group 2 - Allogeneic Human Mesenchymal Stem Cells (hMSCs)

EXPERIMENTAL

Group 2 - Five (5) subjects will be treated with a single administration of 20 million allogeneic mesenchymal stem cell delivered intra-facet via 6 injections of 1.5 mL per injection, total of 9 to 12ml. These subjects will be part of the experimental group.

Biological: Allogeneic Human Mesenchymal Stem Cells (hMSCs)

Group A - Allogeneic Human Mesenchymal Stem Cells (hMSCs)

EXPERIMENTAL

Group A will consist of 15 subjects that will receive 20 million Allogeneic hMSCs delivered via lumbar level injection based on pain originator.

Biological: Allogeneic Human Mesenchymal Stem Cells (hMSCs)

Group B - Placebo

PLACEBO COMPARATOR

Group B will consist of 15 subjects who will receive 2% Ropivicaine and 0.5 cc of betamethasone soluspan (celestone) solution via lumbar level injection based on pain originator.

Drug: Placebo

Interventions

Allogeneic Human Mesenchymal Stem Cells (hMSCs) BIOLOGICAL

A single administration of 20 million allogeneic mesenchymal stem cell delivered intra-facet via 6 injections of 1.5 mL per injection, total of 9 to 12ml.

Also known as: allo-hMSCs, stem cells

Group 2 - Allogeneic Human Mesenchymal Stem Cells (hMSCs); Group A - Allogeneic Human Mesenchymal Stem Cells (hMSCs)

Placebo DRUG

A single administration of 1 cc of 1% lidocaine with 1 cc of 2% Ropivicaine and 0.5 cc of betamethasone soluspan (celestone) solution delivered via intra-facet injection.

Group 1 - Placebo; Group B - Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• In order to participate in this study, a subject must:
• Provide written informed consent.
• Subjects age \>18 and \<75 years at the time of signing the Informed Consent Form.
• Facetogenic back pain diagnosed using the following diagnostic criteria:
• The facet joint may be affected by systemic disease, as rheumatoid arthritis and ankylosing spondylitis, or be site of micro traumatic fractures, osteoarthritis, meniscoid entrapment, synovial impingement, joint subluxation, synovial inflammation, loss of cartilage, and mechanical injury.
• Pain onset at dorsal extension and release at flexion is often considered suggestive for facet pain, even if non-specific, such as maximal tenderness upon deep palpation of posterior elements
• History of temporary improvement with a medial branch block anesthetic injection of the targeted joints
• Axial lumbar pain without radicular symptoms
• Pain on hyperextension, rotation, and lateral bending with physical exam
• Chronic facetogenic pain (≥ 6 months) in patients that have failed conservative management. (This includes but is not limited to a trial of oral medications, 6 weeks of physical therapy, intra-articular injection of the facet joints, and/or facet joint medial branch neurotomy.)
• Diagnosis of lumbar facet joint pain confirmed by analgesic injections.
• Have spinal level L3-4, L4-5 and L5-S1 bilaterally for bilateral pain and same side only for unilateral pain.

You may not qualify if:

• In order to participate in this study, a subject must not:
• Previous surgical intervention for back pain
• Previous mesenchymal stem cell (MSC) injection(s) in to facet joints
• Use of anticoagulation or NSAIDs within 5 days of the injection
• MRI finding of severe high grade lumbar stenosis
• Leg pain exceeding back pain
• Pain worse with flexion maneuvers
• Fracture of lumbar vertebrae
• Be a female who is pregnant, nursing, or of childbearing potential while not practicing effective contraceptive methods. Female subjects must undergo a blood or urine pregnancy test at screening and within 36 hours prior to injection.
• Inability to perform any of the assessments required for endpoint analysis.
• Clinically abnormal screening laboratory values.
• Serious comorbid illness or any other condition that, in the opinion of the investigator, may compromise the safety or compliance of the subject or preclude successful completion of the study.
• Hypersensitivity to dimethyl sulfoxide (DMSO).
• Be an organ transplant recipient.
• Have a clinical history of malignancy within 5 years (i.e., subjects with prior malignancy must be disease free for 5 years), except curatively-treated basal cell carcinoma, squamous cell carcinoma, melanoma in situ or cervical carcinoma, if recurrence occurs.

Sponsors & Collaborators

• Joshua M Hare: lead

Study Sites (1)

ISCI / University of Miami Miller School of Medicine

Miami, Florida, 33136, United States

Location

Related Links

• Interdisciplinary Stem Cell Institute website

MeSH Terms

Conditions

Back Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Andrew Sherman, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Study Sponsor

Study Record Dates

• First Submitted: March 13, 2018
• First Posted: April 4, 2018
• Study Start: December 1, 2020
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: October 20, 2020

Record last verified: 2020-10

Locations

US (1)