Osteoarthritis of Facet Joint of Lumbar SpineNCT03513731
Safety of Adipose-derived Regenerative Cells Injection for Treatment of Osteoarthritis of the Facet Joint
A study testing Adipose-derived stem cell injection and Corticosteroid injection in people with Osteoarthritis of Facet Joint of Lumbar Spine, run by InGeneron, Inc. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Osteoarthritis of Facet Joint of Lumbar Spine
- What is being tested?
- Adipose-derived stem cell injection and Corticosteroid injection
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Dec 2018to Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 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.
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 35Show fewer
- 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.
- Are at a higher risk, in the opinion of the investigator, for bleeding (e.g., bleeding disorder, or taking anticoagulants, except low dose aspirin) or infection (e.g., taking immunosuppressants, have a severe infection, or a history of serious infection).
- Current infection or prior history of spinal infection at the symptomatic level (e.g., discitis, septic arthritis, epidural abscess) or an active systemic infection.
- Severe and/or chronic pain conditions that may potentially confound facet joint symptom assessment, in the opinion of the investigator.
- Cauda equina syndrome.
- Receiving workman's compensation unless litigation is complete.
- Subject is part of a vulnerable population who, in the judgment of the investigator, is unable to give Informed Consent for reasons of incapacity, immaturity, adverse personal circumstances or lack of autonomy. This may include: Individuals with mental disability, persons in nursing homes, children, impoverished persons, persons in emergency situations, homeless persons, nomads, refugees, and those incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces, and persons kept in detention.
- Subjects with documented history of alcohol or drug abuse within the last year.
- Subject is in the opinion of the Investigator or designee, unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason. This includes completion of patient reported outcome instruments.
- Body habitus precluding adequate fluoroscopic visualization for the procedure or the procedure is physically impossible due to inability to inject the facet joint.
- Failed any component of the lumbar neurological exam at baseline (i.e., motor, sensory, or a reflex portion of the exam).
- The subject is receiving immunosuppressant therapy or has a known immunologic or severe autoimmune disease that requires chronic immunosuppressive or immunomodulatory therapy (e.g., human immunodeficiency virus, systemic lupus erythematosus, rheumatoid arthritis, etc.).
- Clinically significant, in the opinion of the investigator, nerve pain (e.g., chronic radiculopathy) or clinically significant sacroiliac joint pain based on targeted, pre-specified physical examination, and, if deemed medically necessary, confirmed by anesthetic injection. If a previously performed anesthetic injection to confirm SI joint pain was performed up to 6 months prior to injection (with documentation indicating no SI joint pain), this does not need to be repeated at screening.
- Symptomatic lumbar intervertebral foraminal stenosis at the symptomatic level resulting in clinically significant spinal nerve root compression, in the opinion of the investigator.
- Symptomatic central vertebral canal, lateral recess stenosis or foraminal stenosis, in the opinion of the investigator.
- Severe instability where, in the opinion of the investigator, surgical interventions to stabilize the segment would be required.
- An acute fracture of the spine. Clinically compromised, in the opinion of the investigator, vertebral bodies at the symptomatic level due to current or past trauma, e.g., sustained a pathological fracture or multiple fractures of vertebrae.
- History of Chronic tobacco and nicotine usage.
- Insufficient amount of subcutaneous tissue to allow recovery of at least 100 mL of adipose tissue.
- Subjects who have document allergy to radiographic agents or sodium citrate or any "caine" type of local anesthetic.
- Subjects with radicular leg pain as determined by investigator
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 1 recruiting
- Recruiting
Sports and Orthopedic Center
Deerfield Beach, Florida, 33064
Ahmad Nasri, (954) 302-3139, anasir@advancedresearchfl.com
- Completed
Sanford Physical Medicine & Rehabilitation Clinic and Sanford Spine Center
Sioux Falls, South Dakota, 57104
About this study
Official title: Safety and Efficacy of Injection of Adipose-derived Regenerative Cells (ADRCs) in Patients Suffering From Osteoarthritis of the Facet Joints
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.
Read the detailed description
Patients will fall into two categories: treatment group (20 subjects) and non-treatment or control group (20 subjects). The treatment group will undergo a small liposuction procedure and receive facet joint osteoarthritis treatment with an ultrasound-guided injection of 5 ml adipose-derived stem cells (ADSCs) into the point of injury. The control group will receive a 5 ml corticosteroid injection into the point of injury
- Being tested
- Adipose-derived stem cell injection, Corticosteroid injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adipose-derived stem cell injectionDevice
Also called ADRCs
ADRC injection into the facet joint
Corticosteroid injectionDrug
Also called steroid injection
Corticosteroid injection into the facet joint
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Adipose-derived stem cell injection |
| Corticosteroid injection | Active comparator | The control group will undergo standard fluoroscopy guided injection of glucocorticoids and local anesthetics. Receives: Drug: Corticosteroid injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety - Incidence of Treatment-Emergent Adverse Events experimental group
Subjects will be monitored for adverse events
Measured: 52 weeks
Secondary outcomes (3)
Efficacy - Change in Pain Scores on the VAS Scale at All Follow-up Visits
Patient outcomes for pain will be recorded (line from 0: no pain to 100:worst pain)
Measured: 6, 12, 26, 52 weeks
Efficacy - Change in Function Scores on the EQ-5D at All Follow-up Visits
Patient outcomes for function will be recorded
Measured: 6, 12, 26, and 52 weeks
Efficacy - Change in Function Scores on the Oswestry Disability Index at All Follow-up Visits
Patient outcomes for function will be recorded. (ODI score is ranged from 0 to 50. Total score is converted in to percent disability. ODI Scoring: 0% to 20% (minimal disability), 21%-40% (moderate disability), 41%-60% (severe disability), 61%-80% (crippled) and 81%-100% (may be bed bound or exaggerating their symptoms).
Measured: 6, 12, 26, and 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2018
- Study start7 Dec 2018
- Primary completionDec 2025 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis of Facet Joint of Lumbar SpineStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- InGeneron, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sanford Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03513731
- Sponsor's protocol ID
- OAFJ-001
- Status last verified
- Aug 2025
- First submitted
- 6 Apr 2018
- Last updated
- 20 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 22961401Toghraie 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.
PubMed 20591677
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Injection of Adipose-derived Regenerative Cells (ADRCs) in Patients Suffering From Osteoarthritis of the Facet Joints
- ClinicalTrials.gov ID
- NCT03513731
- Acronym / sponsor ID
- OAFJ-001
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- InGeneron, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Sanford Health
- Study start
- 7 Dec 2018 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 1 May 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.
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.
Detailed description
Patients will fall into two categories: treatment group (20 subjects) and non-treatment or control group (20 subjects). The treatment group will undergo a small liposuction procedure and receive facet joint osteoarthritis treatment with an ultrasound-guided injection of 5 ml adipose-derived stem cells (ADSCs) into the point of injury. The control group will receive a 5 ml corticosteroid injection into the point of injury
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adipose-derived stem cell injection | Experimental | Device: Adipose-derived stem cell injectionADRC 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. |
| Corticosteroid injection | Active comparator | Drug: Corticosteroid injectionThe control group will undergo standard fluoroscopy guided injection of glucocorticoids and local anesthetics. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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):
- 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
Key exclusion criteria (35 listed)
- 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:
- 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.
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 |
|---|---|---|
| Adipose-derived stem cell injectionAlso: ADRCsADRC injection into the facet joint | Device | Adipose-derived stem cell injection |
| Corticosteroid injectionAlso: steroid injectionCorticosteroid injection into the facet joint | Drug | Corticosteroid injection |
Primary outcome
Safety - Incidence of Treatment-Emergent Adverse Events experimental group
Time frame: 52 weeks
Subjects will be monitored for adverse events
3 secondary outcomes
Efficacy - Change in Pain Scores on the VAS Scale at All Follow-up Visits
Time frame: 6, 12, 26, 52 weeks
Efficacy - Change in Function Scores on the EQ-5D at All Follow-up Visits
Time frame: 6, 12, 26, and 52 weeks
Efficacy - Change in Function Scores on the Oswestry Disability Index at All Follow-up Visits
Time frame: 6, 12, 26, and 52 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2025.
- Background: PubMed 22961401ter 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.
- Background: PubMed 20591677Toghraie 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.
- Individual participant dataSharing planned: No
Related trials for Osteoarthritis of Facet Joint of Lumbar Spine
RecruitingObservational study
Prognostic Factors in Zygapophyseal Osteoarthritis Infiltration: a Prospective Cohort Study
Degenerative Arthropathy of Lumbar Spinal Facet Joint
Recruiting
Mid- or High-flex Rods Versus Low-flex Rods of SpineShape System IV for Treatment of Degenerative Lumbar Spine Diseases
Degenerative Lumbar Spinal Stenosis, Facet Joint Arthrosis
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adipose-derived stem cell injection and Corticosteroid injection in people with Osteoarthritis of Facet Joint of Lumbar Spine, run by InGeneron, Inc. at 2 sites 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 10 inclusion and 35 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: looking for participants now, as of the sponsor's last update on 20 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brian Caballero ((713) 440-9900 ext. 115, bcaballero@ingeneron.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety - Incidence of Treatment-Emergent Adverse Events experimental group (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03513731, which also lists 2 linked publications.
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 Aug 2025.