WithdrawnPhase 2Phase 3ACTRN12611000274976

Adipose-derived stem cells in patients with knee osetoarthritis: A randomised controlled trial evaluating pain, function and cartillage repair


Sponsor

Kade Paterson

Enrollment

60 participants

Start Date

May 15, 2011

Study Type

Interventional

Conditions

Summary

Knee osteoarthritis (OA) is a progressive degenerative condition of articular cartilage and subchondral bone that leads to significant physical and psychological disability, and adversely affects daily function and quality of life. Current treatment of knee OA is associated with limitations and side effects that restrict their ability to effectively treat the symptoms of the condition and stop its progression. Recent research has demonstrated that Human adipose-derived stem cells (ADSCs) are safe for use in Humans and can differentiate into cartilage and bone, suggesting a potential treatment in osteoarthritis. This study aims to assess the changes in pain, cartilage and bone appearance, activity levels and lower extremity functional ability of patients with knee OA following intra-articular ADSC injection compared to usual treatment of Hylan G-F 20 (Synvisc [Registered Trademark]).


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 80 Yearss

Inclusion Criteria1

  • A diagnosis of OA assessed via the International Cartilage Repair Society guidelines and a visual analogue pain score of greater than 50 out of 100

Exclusion Criteria1

  • No systemic or inflammatory joint disease, no history of crystalline or neuropathic arthropathy, no cancer or other tumour-like lesions, not pregnant or lactating, not drug abusing, no other intra articular lesion in the previous six months, no allergy to any test substance and not immunosuppressed

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Interventions

Three injections each of 5ml stromal vascular fraction containing adipose-derived stem cells two months apart. Time-points for injections: 1) initial injection, 2) two months following initial injecti

Three injections each of 5ml stromal vascular fraction containing adipose-derived stem cells two months apart. Time-points for injections: 1) initial injection, 2) two months following initial injection and 3) four months following initial injection. This results in a total treatment duration of five months.


Locations(1)

Australia

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