A study using non-expanded stem cells for the treatment of early osteoarthritis of the knee (focal chondral defects) in comparison to standard conservative management.

Phase 2

• Conditions: Focal chondral lesions of the knee; Musculoskeletal - Other muscular and skeletal disorders

• Registration Number: ACTRN12616001259437
• Lead Sponsor: Cell-Innovations Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-09-08
• Last Update Posted: 21 March 2022

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

1. Focal chondral lesions of the knee (as evidenced by MRI scan) with symptomatic pain and less than or equal to 6 cm2 in size.
2. Greater than 6 months knee pain with the index side (left or right) predominately on one side
3. A KOOS pain score greater than or equal to 65
4. Adequate blood chemistry and hematopoietic, renal, cardiovascular, respiratory, immunological function

Exclusion Criteria

1. Subjects who have received investigational agents within 4 weeks (or 5 half-lives) of SVF/placebo infusion.
2. Presence of clinically significant acute or unstable cardiovascular, cerebrovascular (stroke), renal, gastrointestinal, pulmonary, immunological (viral hepatitis, or cirrhosis), endocrine, or central nervous system disorders.
3. Subjects who have had active neoplastic disease in the previous 3 years.

Study & Design

• Study Type: Interventional
• Study Design: Not specified