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

Withdrawn before enrolling · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Facetogenic Back Pain, Back Pain

In brief

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.

Key facts

Study ID: NCT03487731
Run by: Joshua M Hare
People needed: 0
Starts: 2020-12-01
Expected to finish: 2025-12-01
Last updated by the study team: 2020-10-20

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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.
Have a non-pulmonary condition that limits lifespan to < 1 year.
Have a history of drug or alcohol abuse within the past 24 months.
Be serum positive for HIV, hepatitis BsAg or Viremic hepatitis C.
Be currently participating (or participated within the previous 30 days) in an investigational therapeutic or device trial.

Where it is running

ISCI / University of Miami Miller School of Medicine — Miami, Florida, United States

Full record on ClinicalTrials.gov

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