Actively Recruiting
Safety of Adipose-derived Regenerative Cells Injection for Treatment of Osteoarthritis of the Facet Joint
Led by InGeneron, Inc. · Updated on 2025-08-20
40
Participants Needed
2
Research Sites
381 weeks
Total Duration
On this page
Sponsors
I
InGeneron, Inc.
Lead Sponsor
S
Sanford Health
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Safety of Adipose-derived Regenerative Cells Injection for Treatment of Osteoarthritis of the Facet Joint
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female subjects, between 18 and 75 years of age
- Documented diagnosis of facet joint osteoarthritis from L1 to S1
- Chronic low back pain for at least 6 months
- Failed at least 3 months of conservative back pain treatments
- Completed supervised physical therapy for low back pain
- Radiographic evidence of lumbar facet joint osteoarthritis at symptomatic level
- Baseline pain score of at least 4 on a 0-10 scale over 24 hours
- Demonstrated more than 80% pain relief after diagnostic injection
- Signed informed consent and willingness to attend all scheduled examinations
You will not qualify if you...
- Pregnant or nursing women, or planning pregnancy within 12 months
- Females of childbearing age not using accepted birth control methods
- Extreme obesity with BMI over 40
- Lumbar intradiscal injections less than 3 months prior, except certain diagnostic or minor injections
- Epidural steroid injections or facet joint nerve treatments within 8 weeks prior
- Recent chronic use of systemic corticosteroids equivalent to prednisone 210 mg/day
- Active malignancy or history within 2 years, except certain skin or cervical cancers fully excised
- Participation in another ongoing clinical trial
- Prior stem cell or biological therapy for intervertebral disc or facet joint
- High baseline morphine equivalent dose over 40mg/day
- Bleeding or infection risk factors or current infection at symptomatic level
- Severe or chronic pain conditions confounding assessment
- Cauda equina syndrome
- Receiving workman's compensation with ongoing litigation
- Vulnerable populations unable to give informed consent
- History of alcohol or drug abuse in past year
- Inability to comply with study requirements
- Body habitus preventing proper procedure visualization
- Failed neurological exam components at baseline
- Immunosuppressant therapy or severe autoimmune diseases
- Significant nerve or sacroiliac joint pain
- Symptomatic lumbar stenosis causing nerve root compression
- Severe spinal instability requiring surgery
- Acute or compromised spinal fractures
- Chronic tobacco and nicotine use
- Insufficient adipose tissue for liposuction
- Allergies to radiographic agents, sodium citrate, or local anesthetics
- Radicular leg pain as determined by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Sports and Orthopedic Center
Deerfield Beach, Florida, United States, 33064
Actively Recruiting
2
Sanford Physical Medicine & Rehabilitation Clinic and Sanford Spine Center
Sioux Falls, South Dakota, United States, 57104
Completed
Research Team
B
Brian Caballero
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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