Intra-articular Injection in the Knee of Adipose Derived Stromal Cells and Platelet Rich Plasma for Osteoarthritis

Bioheart

Status and phase: Completed; Phase 1

Conditions: Osteoarthritis

Treatments: Biological: Intra-articular injection of SVF plus PRP

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03089762

AAH/02/12

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

SVF and PRP

Experimental group

Treatment:

Biological: Intra-articular injection of SVF plus PRP