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.
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 Ltd
32 participants
Feb 1, 2024
Interventional
Conditions
Summary
The primary objective of this study is to determine the safety and tolerability of autologous stromal vascular fraction (SVF) and PRP in comparison to standard conservative management of patients with focal chondral lesions of the knee. Secondary objectives are intended to measure differences between standard treatment and SVF based therapies including improvement of pain and mobility, quality of life and MRI to assess disease modifying activity.
Eligibility
Inclusion Criteria4
- Focal chondral lesions of the knee (as evidenced by MRI scan) with symptomatic pain and less than or equal to 6 cm2 in size.
- Greater than 6 months knee pain with the index side (left or right) predominately on one side
- A KOOS pain score greater than or equal to 65
- Adequate blood chemistry and hematopoietic, renal, cardiovascular, respiratory, immunological function
Exclusion Criteria3
- Subjects who have received investigational agents within 4 weeks (or 5 half-lives) of SVF/placebo infusion.
- Presence of clinically significant acute or unstable cardiovascular, cerebrovascular (stroke), renal, gastrointestinal, pulmonary, immunological (viral hepatitis, or cirrhosis), endocrine, or central nervous system disorders.
- Subjects who have had active neoplastic disease in the previous 3 years.
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Interventions
This study will look to assess the safety and response of focal chondral lesions of the knee to injection protocols of stromal vascular fraction (SVF) and platelet rich plasma (PRP) in comparison to accepted conservative mangement. Thirty two participants will be enrolled in the study and randomly separated into 2 study groups. Group 1: [SVF (IA) + PRP (IA)] at Day 0 + PRP (IA) at Days 7, 14 & 28 Group 2: accepted conservative management including: simple analgesics, weight loss education, regular exercises, biomechanical adjustment Autologous non-expanded SVF from adipose (fat) will be used due to the ease of harvest (liposuction) and safety. On average 100 million cells are injected into the joint. Adipose tissue is removed by lipo-aspiration (about 60 minutes). The fat is processed on-site to isolate the cells (this process takes up to 40 mins). The suspension of stromal stem cells is injected into the knee joint under ultrasound guidance. The PRP (3ml) process involves separating out platelets with plasma from a small amount of blood taken, and takes about 15 mins. The harvesting of adipose and the PRP processing will be performed on the same day as the injection of SVF and PRP, respectively.
Locations(1)
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ACTRN12616001259437