Intra-articular Injection in the Knee of Adipose Derived Stromal Cells and Platelet Rich Plasma for Osteoarthritis
Phase 1
Completed
- Conditions
- Osteoarthritis
- Interventions
- Biological: Intra-articular injection of SVF plus PRP
- Registration Number
- NCT03089762
- Lead Sponsor
- Bioheart, Inc.
- Brief Summary
Stromal vascular fraction (SVF) can easily be obtained from a mini-lipoaspirate procedure of fat tissue and platelet rich plasma (PRP) can be obtained from peripheral blood. Evaluated the safety and preliminary efficacy of administering SVF and PRP intra-articularly into patients with osteoarthritis grade 1 and 2.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
Inclusion Criteria
- patients age 50 or older who present with symptomatic primary osteoarthritis of the knee
- daily pain for the previous 3 months
- analgesics usage at least once a week
- less than 30 minutes of morning stiffness
- WOMAC score of ≤ 75 in the target knee
- Brandt Radiographic Grading Scale of Osteoarthritis grade 1 and 2
Exclusion Criteria
- evidence of secondary knee osteoarthritis
- severe osteoarthritis (Joint space width - JSW < 2 mm)
- prior intra articular injections within the previous one year prior to inclusion
- patients with clinically significant systemic disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description SVF and PRP Intra-articular injection of SVF plus PRP -
- Primary Outcome Measures
Name Time Method WOMAC (Western Ontario and McMaster Universities Arthritis Index) 1 year
- Secondary Outcome Measures
Name Time Method Six minute walk distance 1 year