InGeneron, Inc.
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.
Osteoarthritis of Facet Joint of Lumbar Spine
Adipose-derived stem cell injection
Corticosteroid injection
NA
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 Type : | INTERVENTIONAL |
Estimated Enrollment : | 40 participants |
Masking : | NONE |
Masking Description : | It is a single-blinded trial in which the radiologists are blinded. Subjects and the Investigator are unblinded. |
Primary Purpose : | TREATMENT |
Official Title : | Safety and Efficacy of Injection of Adipose-derived Regenerative Cells (ADRCs) in Patients Suffering From Osteoarthritis of the Facet Joints |
Actual Study Start Date : | 2018-12-07 |
Estimated Primary Completion Date : | 2024-12-31 |
Estimated Study Completion Date : | 2025-06-30 |
Information not available for Arms and Intervention/treatment
Ages Eligible for Study: | 18 Years to 75 Years |
Sexes Eligible for Study: | ALL |
Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
RECRUITING
Sports and Orthopedic Center
Coral Springs, Florida, United States, 33067
ACTIVE NOT RECRUITING
Sanford Physical Medicine & Rehabilitation Clinic and Sanford Spine Center
Sioux Falls, South Dakota, United States, 57104