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

Conditions

• Osteoarthritis of Facet Joint of Lumbar Spine

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Adipose-derived stem cell injection — DEVICE
  ADRC injection into the facet joint
• Corticosteroid injection — DRUG
  Corticosteroid injection into the facet joint

Study Details

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.

Key Dates

Start date

Dec 7, 2018

Status verified

Aug 2025

Primary completion

Dec 31, 2025

Completion

Apr 30, 2026

Study Design

Enrollment

40 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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.

Primary Outcome Measure

Safety - Incidence of Treatment-Emergent Adverse Events experimental group [ Time Frame: 52 weeks ]

Central Contacts

• Brian Caballero
  (713) 440-9900
  [email protected]

Locations (2)

Find similar trials in Deerfield Beach, FL