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

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ClinicalTrials.gov Identifier: NCT03487731
Recruitment Status : Not yet recruiting
First Posted : April 4, 2018
Last Update Posted : July 23, 2019
Sponsor:
Information provided by (Responsible Party):
Joshua M Hare, University of Miami

Tracking Information
First Submitted Date  ICMJE March 13, 2018
First Posted Date  ICMJE April 4, 2018
Last Update Posted Date July 23, 2019
Estimated Study Start Date  ICMJE December 1, 2019
Estimated Primary Completion Date December 1, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 27, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03487731 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 27, 2018)
  • 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.
  • 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.
  • Death from any cause. [ Time Frame: Baseline, Month 3, and Month 6 ]
    Death from any cause.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Allogeneic Human Mesenchymal Stem Cell Injection in PAtieNts With FaceTogenic Back Pain
Official Title  ICMJE 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
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Facetogenic Back Pain
  • Back Pain
Intervention  ICMJE
  • 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
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Placebo
  • 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.
    Intervention: Biological: Allogeneic Human Mesenchymal Stem Cells (hMSCs)
  • 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.
    Intervention: Biological: Allogeneic Human Mesenchymal Stem Cells (hMSCs)
  • 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.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: March 27, 2018)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2025
Estimated Primary Completion Date December 1, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Joshua M Hare, MD 305-243-5579 JHARE@med.miami.edu
Contact: Andrew Sherman, MD 305-243-4567 ASherman@med.miami.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03487731
Other Study ID Numbers  ICMJE 20180018
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Joshua M Hare, University of Miami
Study Sponsor  ICMJE Joshua M Hare
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Andrew Sherman, MD University of Miami
PRS Account University of Miami
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP