ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03487731
Recruitment Status : Not yet recruiting
First Posted : April 4, 2018
Last Update Posted : September 25, 2018
Sponsor:
Information provided by (Responsible Party):
Joshua M Hare, University of Miami

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.

Condition or disease Intervention/treatment Phase
Facetogenic Back Pain Back Pain Biological: Allogeneic Human Mesenchymal Stem Cells (hMSCs) Drug: Placebo Phase 1 Phase 2

Detailed Description:

There are 40 subjects that will be randomized into the trial into one of 4 groups. In the pilot phase 5 subjects will be enrolled into Group 1, and another 5 subjects will be enrolled into Group 2. Subjects in group 1 will receive placebo but will be eligible for a cross over phase where they will receive a injection of the study investigational product.

In the pilot phase, the first three (3) subjects in each treatment group will not be treated less than 10 days apart.

Following the pilot study, thirty (30) subjects will be scheduled to undergo CT guided facet injection of the lumbar facet joints using a posterior approach after meeting all inclusion/exclusion criteria and baseline evaluation.

Eligible participants will be randomized to either Group A or Group B.Group A will consist of 15 subjects that will receive 20 million Allogeneic hMSCs. Group B will receive placebo.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase I/II, Randomized, Blinded and Placebo-controlled Trial to EValuate the Safety and Potential Efficacy of Allogeneic Human Mesenchymal Stem Cell Injection in PAtieNts With FaceTogenic Back Pain
Estimated Study Start Date : January 1, 2019
Estimated Primary Completion Date : September 1, 2025
Estimated Study Completion Date : September 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Placebo Comparator: Group 1 - Placebo
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
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.

Experimental: Group 2 - Allogeneic Human Mesenchymal Stem Cells (hMSCs)
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)
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.
Other Names:
  • allo-hMSCs
  • stem cells

Experimental: Group A - Allogeneic Human Mesenchymal Stem Cells (hMSCs)
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)
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.
Other Names:
  • allo-hMSCs
  • stem cells

Placebo Comparator: Group B - Placebo
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
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.




Primary Outcome Measures :
  1. Incidence of any treatment-emergent serious adverse events [ Time Frame: at one-month post injection ]
    Incidence (at one-month post injection) of any treatment-emergent serious adverse events.


Secondary Outcome Measures :
  1. Difference in subject quality of life assessment - SF-12 [ Time Frame: Baseline, Month 3, and Month 6 ]
    Difference in subject quality of life assessment - SF-12 to assess if there is improvement in health via this health survey.

  2. Difference in subject quality of life assessment - Oswestry Low Back Pain [ Time Frame: Baseline, Month 3, and Month 6 ]
    Difference in subject quality of life assessment - Oswestry Low Back Pain where the scores are defined by percentage with 0 to 20% showing minimal disability and 81-100% showing severe disabling symptoms.

  3. Death from any cause. [ Time Frame: Baseline, Month 3, and Month 6 ]
    Death from any cause.

  4. Change in pain using the Numeric rating scale [ Time Frame: Baseline and Month 6 ]
    Change between baseline and 6 months in pain using the Numeric Rating Scale (NRS) scale. This is assessed on a scale from 0 to 10 with 0 being no pain and 10 being the worst pain.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

In order to participate in this study, a subject must:

  1. Provide written informed consent.
  2. Subjects age >18 and <75 years at the time of signing the Informed Consent Form.
  3. 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
  4. 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.)
  5. Diagnosis of lumbar facet joint pain confirmed by analgesic injections.
  6. Have spinal level L3-4, L4-5 and L5-S1 bilaterally for bilateral pain and same side only for unilateral pain.

Exclusion Criteria:

In order to participate in this study, a subject must not:

  1. Previous surgical intervention for back pain
  2. Previous mesenchymal stem cell (MSC) injection(s) in to facet joints
  3. Use of anticoagulation or NSAIDs within 5 days of the injection
  4. MRI finding of severe high grade lumbar stenosis
  5. Leg pain exceeding back pain
  6. Pain worse with flexion maneuvers
  7. Fracture of lumbar vertebrae
  8. 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.
  9. Inability to perform any of the assessments required for endpoint analysis.
  10. Clinically abnormal screening laboratory values.
  11. 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.
  12. Hypersensitivity to dimethyl sulfoxide (DMSO).
  13. Be an organ transplant recipient.
  14. 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.
  15. Have a non-pulmonary condition that limits lifespan to < 1 year.
  16. Have a history of drug or alcohol abuse within the past 24 months.
  17. Be serum positive for HIV, hepatitis BsAg or Viremic hepatitis C.
  18. Be currently participating (or participated within the previous 30 days) in an investigational therapeutic or device trial.

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): NCT03487731


Contacts
Contact: Joshua M Hare, MD 305-243-5579 JHARE@med.miami.edu
Contact: Andrew Sherman, MD 305-243-4567 ASherman@med.miami.edu

Locations
United States, Florida
ISCI / University of Miami Miller School of Medicine Not yet recruiting
Miami, Florida, United States, 33136
Contact: Joshua M Hare, MD    305-243-5579    jhare@med.miami.edu   
Contact: Coordinators    305-243-7444    ISCIStudyInfo@miami.edu   
Sub-Investigator: Joshua M Hare, MD         
Principal Investigator: Andrew Sherman, MD         
Sponsors and Collaborators
Joshua M Hare
Investigators
Principal Investigator: Andrew Sherman, MD University of Miami

Additional Information:
Responsible Party: Joshua M Hare, Study Sponsor, University of Miami
ClinicalTrials.gov Identifier: NCT03487731     History of Changes
Other Study ID Numbers: 20180018
First Posted: April 4, 2018    Key Record Dates
Last Update Posted: September 25, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Joshua M Hare, University of Miami:
stem cells
back pain

Additional relevant MeSH terms:
Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Betamethasone
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents