ACTRN12616001259437
Not yet recruiting
Phase 2
A proof-of-concept study on the safety and efficacy of autologous stromal vascular fraction and platelet rich plasma for the treatment of symptomatic focal chondral lesions of the knee in comparison to accepted conservative management.
Cell-Innovations Pty Ltd0 sites32 target enrollmentSeptember 8, 2016
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Cell-Innovations Pty Ltd
- Enrollment
- 32
- Status
- Not yet recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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