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

October 16, 2020 updated by: Joshua M Hare

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • ISCI / University of Miami Miller School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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:
  • stem cells
  • allo-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.
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:
  • stem cells
  • allo-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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
at one-month post injection

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Baseline, Month 3, and Month 6
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.
Baseline, Month 3, and Month 6
Death from any cause.
Time Frame: Baseline, Month 3, and Month 6
Death from any cause.
Baseline, Month 3, and Month 6
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.
Baseline and Month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Joshua M Hare

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Andrew Sherman, MD, University of Miami

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2020

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2025

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 13, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 4, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 20, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 16, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20180018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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