Safety and Efficacy of Injection of Adipose-derived Regenerative Cells (ADRCs) in Patients Suffering From Osteoarthritis of the Facet Joints

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device, Drug
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

Locations
United States
Florida
Sports and Orthopedic Center
RECRUITING
Deerfield Beach
South Dakota
Sanford Physical Medicine & Rehabilitation Clinic and Sanford Spine Center
COMPLETED
Sioux Falls
Contact Information
Primary
Brian Caballero
bcaballero@ingeneron.com
(713) 440-9900
Time Frame
Start Date: 2018-12-07
Estimated Completion Date: 2026-04
Participants
Target number of participants: 40
Treatments
Experimental: Adipose-derived stem cell injection
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.
Active_comparator: Corticosteroid injection
The control group will undergo standard fluoroscopy guided injection of glucocorticoids and local anesthetics.
Related Therapeutic Areas
Sponsors
Collaborators: Sanford Health
Leads: InGeneron, Inc.

This content was sourced from clinicaltrials.gov