Adipose-Derived Stem Cell Injections for Knee Osteoarthritis

• Status: Recruiting
• Trial end date: 2020-06-01
• Target enrollment: 45
• Participant gender: All

Summary

This is a non-surgical trial comparing the clinical and functional outcomes of patients with osteoarthritis treated with Intra-articular injection of autologous Adipose-Derived Stem Cells (ADSC) combined with platelet-rich plasma (PRP) versus conventional therapy of Intra-articular injection of corticosteroid.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University

Criteria

Inclusion Criteria:

• Age between 35 and 75 years-old

• Diagnosis of pre-existing osteoarthritis of the joint by Kellgren-Lawrence Grade 2 or 3.

• Working understanding of the English language and able to fully understand the procedure

• Capable of providing informed consent

• Able to complete online, in-person or phone surveys for the purposes of follow-up

• Capable of understanding pre- and post-procedure care instructions

• Ambulatory at baseline

• Previous trial and failure of conservative therapy consisting of a minimum of 6 weeks of physical therapy and trial of anti-inflammatory medications if not contraindicated, with or without concomitant bracing and/or injections.

Exclusion Criteria:

• Age < 35 or > 75 years old

• Radiographs demonstrating either no, little or severe osteoarthritis (Kellgren-Lawrence Grade 0, 1 )

• Prior total or partial joint replacement surgery or a surgery involving cartilage regeneration (microfracture, ACI, etc)

• Previous cortisone and/or Hyaluronic acid intra-articular injection within the last 3 months

• Co-morbidity with rheumatologic condition, inflammatory arthritis

• Currently undergoing immunomodulatory therapy

• Uncontrolled endocrine disorder

• BMI >35

• Current diagnosis of osteomyelitis, human immunodeficiency virus (HIV-1, -2) and/or hepatitis C (HCV), infection and poorly controlled diabetes (HgA1C >7.0)

• Pregnancy or planned pregnancy

• previous stem cell injection into treatment joint

• Patient scheduled to undergo any concomitant surgical procedures.

• Coagulopathy or anticoagulant treatment

• Chronic pain involving multiple body parts or opioid medication management