Facetogenic Back PainPhase 1/2VALIANTNCT03487731
Allogeneic Human Mesenchymal Stem Cell Injection in PAtieNts With FaceTogenic Back Pain
A Phase 1/2 study testing Allogeneic Human Mesenchymal Stem Cells (hMSCs) in people with Facetogenic Back Pain and Back Pain, run by Joshua M Hare at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Facetogenic Back Pain, Back Pain
- What is being tested?
- Allogeneic Human Mesenchymal Stem Cells (hMSCs)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2020to 1 Dec 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
ISCI / University of Miami Miller School of Medicine
Miami, Florida, 33136
About this study
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
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.
Read the 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.
- Conditions
- Facetogenic Back Pain, Back Pain
- Being tested
- Allogeneic Human Mesenchymal Stem Cells (hMSCs), Placebo
- Keywords
- stem cells, back pain
- Medical subject headings
- Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allogeneic Human Mesenchymal Stem Cells (hMSCs)Biological
Also called allo-hMSCs, stem cells
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.
PlaceboDrug
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of any treatment-emergent serious adverse events
Incidence (at one-month post injection) of any treatment-emergent serious adverse events.
Measured: at one-month post injection
Secondary outcomes (4)
Difference in subject quality of life assessment - SF-12
Difference in subject quality of life assessment - SF-12 to assess if there is improvement in health via this health survey.
Measured: Baseline, Month 3, and Month 6
Difference in subject quality of life assessment - Oswestry Low Back Pain
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.
Measured: Baseline, Month 3, and Month 6
Death from any cause.
Death from any cause.
Measured: Baseline, Month 3, and Month 6
Change in pain using the Numeric rating scale
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.
Measured: Baseline and Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2018
- Study start1 Dec 2020 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Why it stopped: PI decided to not proceed with study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facetogenic Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joshua M Hare
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Joshua M Hare, University of Miami
- Investigators
- Andrew Sherman, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03487731
- Sponsor's protocol ID
- 20180018
- Acronym
- VALIANT
- Status last verified
- Oct 2020
- First submitted
- 13 Mar 2018
- Last updated
- 20 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03487731
- Acronym / sponsor ID
- VALIANT / 20180018
- Conditions
- Facetogenic Back Pain, Back Pain
- Keywords
- stem cells, back pain
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI decided to not proceed with study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Joshua M HareUniversity, hospital or other
- Study start
- 1 Dec 2020 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 4 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 - Placebo | Placebo comparator | Drug: PlaceboGroup 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. |
| Group 2 - Allogeneic Human Mesenchymal Stem Cells (hMSCs) | Experimental | Biological: 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. |
| Group A - Allogeneic Human Mesenchymal Stem Cells (hMSCs) | Experimental | Biological: 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. |
| Group B - Placebo | Placebo comparator | Drug: PlaceboGroup 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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:
- 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.
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Allogeneic Human Mesenchymal Stem Cells (hMSCs)Also: allo-hMSCs, stem cellsA 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. | Biological | Group 2 - Allogeneic Human Mesenchymal Stem Cells (hMSCs), Group A - Allogeneic Human Mesenchymal Stem Cells (hMSCs) |
| PlaceboA 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. | Drug | Group 1 - Placebo, Group B - Placebo |
Primary outcome
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.
4 secondary outcomes
Difference in subject quality of life assessment - SF-12
Time frame: 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
Death from any cause.
Time frame: Baseline, Month 3, and Month 6
Change in pain using the Numeric rating scale
Time frame: Baseline and Month 6
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2020.
- Interdisciplinary Stem Cell Institute websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Facetogenic Back Pain
Recruiting
Trans-arterial Embolization for the Treatment of Facet Pain Due to Facet Arthropathy
Facet Joint Arthropathy, Pain
RecruitingPhase 1
Dose Escalation Pilot Study to Evaluate the Safety of Alocyte for the Treatment of Facetogenic Back Pain
Facet Joints; Degeneration, Back Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Sherman, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Allogeneic Human Mesenchymal Stem Cells (hMSCs) in people with Facetogenic Back Pain and Back Pain, run by Joshua M Hare at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of any treatment-emergent serious adverse events (time frame: at one-month post injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2020.