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

Back Pain Clinical Trial

— VALIANT  

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03487731
• Other study ID #: 20180018
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• Start date: December 1, 2020
• Est. completion date: December 1, 2025

Study information

• Verified date: October 2020
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Facetogenic Back Pain

Intervention

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.

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.

Locations

Country	Name	City	State
United States	ISCI / University of Miami Miller School of Medicine	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Joshua M Hare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of any treatment-emergent serious adverse events	Incidence (at one-month post injection) of any treatment-emergent serious adverse events.	at one-month post injection
Secondary	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.	Baseline, Month 3, and Month 6
Secondary	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.	Baseline, Month 3, and Month 6
Secondary	Death from any cause.	Death from any cause.	Baseline, Month 3, and Month 6
Secondary	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.	Baseline and Month 6

External Links

•   Interdisciplinary Stem Cell Institute website