Safety of Adipose-derived Regenerative Cells Injection for Treatment of Osteoarthritis of the Facet Joint

NCT03513731 | Recruiting FDA Device

• 1 other identifier: OAFJ-001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

This is a prospective, randomized, active controlled, single site safety and efficacy study in subjects suffering from chronic lumber back pain due to facet joint osteoarthritis comparing a single ADRC injection generated with the Transpose® RT system into the facet joint.

Conditions

Osteoarthritis of Facet Joint of Lumbar Spine

Outcome Measures

Primary Outcomes (1)

• Safety - Incidence of Treatment-Emergent Adverse Events experimental group

  Subjects will be monitored for adverse events

  52 weeks

Secondary Outcomes (3)

• Efficacy - Change in Pain Scores on the VAS Scale at All Follow-up Visits

  6, 12, 26, 52 weeks

• Efficacy - Change in Function Scores on the EQ-5D at All Follow-up Visits

  6, 12, 26, and 52 weeks

• Efficacy - Change in Function Scores on the Oswestry Disability Index at All Follow-up Visits

  6, 12, 26, and 52 weeks

Study Arms (2)

Adipose-derived stem cell injection

EXPERIMENTAL

ADRC treatment group will receive ADRCs yielded from processing of lipoaspirate by a fluoroscopic-guided injection into the affected segment. The segment will consist of 2 joints per level and up to two levels (no more than 4 joints) injected during the procedure.

Device: Adipose-derived stem cell injection

Corticosteroid injection

ACTIVE COMPARATOR

The control group will undergo standard fluoroscopy guided injection of glucocorticoids and local anesthetics.

Drug: Corticosteroid injection

Interventions

Adipose-derived stem cell injection DEVICE

ADRC injection into the facet joint

Also known as: ADRCs

Adipose-derived stem cell injection

Corticosteroid injection DRUG

Corticosteroid injection into the facet joint

Also known as: steroid injection

Corticosteroid injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female subjects, between 18 and 75 years of age.
• Have documented the diagnosis of facet joint osteoarthritis from L1 to S1 in the opinion of the investigator.
• Have a documented diagnosis of symptomatic facet joint syndrome is defined as the following (subject must meet all the listed conditions):
• Chronic low back pain for at least 6 months.
• Have failed 3 months of conservative back pain care. (Conservative treatment regimens may include any or all of the following: initial rest, medications \[e.g., anti-inflammatory, analgesics, narcotics/opioids, muscle relaxants\], massage, acupuncture, chiropractic manipulations, activity modification, home-directed lumbar exercise program, and non- invasive pain control treatments or procedures).
• Have undergone supervised physical therapy, such as daily walking routines, therapeutic exercises, and back education programs specifically for the treatment of low back pain.
• Change from normal spine morphology at the symptomatic level as defined by Radiographic evaluation for Lumbar facet joint osteoarthritis.
• The baseline pain score of at least 4 on a pain scale of 0-10, over 24 hours
• Subjects demonstrate \>80% relief of their pain after diagnostic injection.
• Signed informed consent indicating the subject is willing to undergo treatment and willing to be available for each examination scheduled over the study duration

You may not qualify if:

• Female subjects who are pregnant or nursing, or women planning to become pregnant within 12 months following treatment.
• Females of childbearing age who have not used or do not plan to use acceptable birth control measures, for the duration of the study. Oral, injected or implanted hormonal contraceptive, barrier methods (condom or diaphragm with spermicide), intrauterine device, surgical sterilization, transdermal delivery, congenital sterility or sexual abstinence are considered acceptable forms of birth control. If sexually active the subject must have been using one of the accepted birth control methods at least one months prior to study entry.
• Extreme obesity, as defined by NIH Clinical Guidelines Body Mass Index (BMI \> 40)
• Any lumbar intradiscal injection, including steroids, at the symptomatic or adjacent discs less than 3 months prior to treatment injection, except for the following injections performed at least 2 weeks prior to study treatment:
• Contrast medium (discography or other diagnostic injection)
• NSAIDs
• Nerve-blocking anesthetics (e.g., lidocaine, bupivacaine)
• Antibiotics
• Saline
• Epidural steroid injections, prior lumbar facet joint injection, medial branch block or radiofrequency ablation of facet joint nerves within 8 weeks prior to treatment injection.
• Have received chronic (more than 7 consecutive days) treatment with systemic corticosteroids at a dose equivalent to prednisone ≥ 10 mg/day within 14 days prior to an injection procedure.
• Active malignancy or tumor as a source of symptoms or history of malignancy within the 2 years prior to enrollment on the study, except history of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or squamous cell carcinoma of the cervix if fully excised and with clear margins.
• Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.
• Have been a recipient of prior allogeneic stem cell/progenitor cell therapy for any indication or autologous stem cell/progenitor cell therapy or other biological intervention to repair the target intervertebral disc or facet joint.
• An average baseline morphine equivalent dose (MED) of \>40mg/day collected during the screening visit.

Sponsors & Collaborators

• InGeneron, Inc.: lead
• Sanford Health: collaborator

Study Sites (2)

Sports and Orthopedic Center

Deerfield Beach, Florida, 33064, United States

RECRUITING

Sanford Physical Medicine & Rehabilitation Clinic and Sanford Spine Center

Sioux Falls, South Dakota, 57104, United States

COMPLETED

Related Publications (2)

• ter Huurne M, Schelbergen R, Blattes R, Blom A, de Munter W, Grevers LC, Jeanson J, Noel D, Casteilla L, Jorgensen C, van den Berg W, van Lent PL. Antiinflammatory and chondroprotective effects of intraarticular injection of adipose-derived stem cells in experimental osteoarthritis. Arthritis Rheum. 2012 Nov;64(11):3604-13. doi: 10.1002/art.34626.

  PMID: 22961401 BACKGROUND

• Toghraie FS, Chenari N, Gholipour MA, Faghih Z, Torabinejad S, Dehghani S, Ghaderi A. Treatment of osteoarthritis with infrapatellar fat pad derived mesenchymal stem cells in Rabbit. Knee. 2011 Mar;18(2):71-5. doi: 10.1016/j.knee.2010.03.001. Epub 2010 Jun 29.

  PMID: 20591677 BACKGROUND

MeSH Terms

Interventions

Adrenal Cortex Hormones; Steroids

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Fused-Ring Compounds; Polycyclic Compounds

Central Study Contacts

Brian Caballero

CONTACT

(713) 440-9900; bcaballero@ingeneron.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: It is a single-blinded trial in which the radiologists are blinded. Subjects and the Investigator are unblinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2018
• First Posted: May 1, 2018
• Study Start: December 7, 2018
• Primary Completion: December 1, 2025
• Study Completion: April 1, 2026
• Last Updated: August 20, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)