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.

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12616001259437

Enrollment

Registered

2016-09-08

Start date

2024-02-01

Completion date

2025-02-03

Last updated

2026-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Healthy volunteers

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.

Outcome results