Evaluation of the safety of t-SVF in osteoarthritis

Phase 1

Recruiting

• Conditions: Condition 1: Osteoarthirits. Condition 2: Osteoarthritis of the knee.; Polyosteoarthritis; Osteoarthritis of knee

• Registration Number: IRCT20181205041860N2
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 26 June 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Unilateral or bilateral knee osteoarthritis is diagnosed using MRI imaging and is class II, III according to Quaterbridge criteria.
There is complete damage to the thickness of the cartilage tissue, whose size is less than 1.5 cm in terms of surface.
WOMAC test of the patient should be less than 8
The age of the patient should be between 50 and 75
Body mass index of patients should be between 22 and 37.

Exclusion Criteria

Damage to Minsk
There is a complete damage to the thickness of the cartilage tissue, which is more than 1.5 cm in terms of surface.
Osteochondritis dissections
Parameniscal and Bakers or ganglion cysts
Lipoma arborescens
Hoffa'spad syndrome
Severe swelling and inflammation in the knee area
Rupture of knee ligaments
Pain caused by dislocation or fracture of kneecap
The classification of knee injury should be based on Quterbridge Class IV criteria.
Classification of knee injury should be based on Quterbridge class IV criteria, but the size of the lesion should be more than 1.5 cm.
People who have been injected with drugs such as corticosteroids, Vasosupplementation and cell products including SVF, stem cells, platelet-enriched plasma in the last 6 months.
People who have had knee surgery in the last 6 months.
People who have a history of systemic diseases, including diabetes, bleeding disorders.
Women who were pregnant during the study or were planning to become pregnant.
People who have received oral steroids for a long time.
History of any chemotherapy or radiation therapy in both parts of the knee and the fat tissue donor area

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome of this study is safety, which will be evaluated with the occurrence of side effects in patients. Timepoint: The patient will be visited one and six days as well as 1 and 6 months after injection. But during this time, if patients have any abnormal clinical symptoms, you will be counseled or visited by telephone or in person. Method of measurement: In order to check safety, different parameters such as infection, inflammation, formation of fibrotic tissue, local edema, local erythema, pain and mortality will be evaluated through clinical evaluations, blood tests, MRI.

Secondary Outcome Measures

Name	Time	Method
Cartilage regeneration. Timepoint: After 6 months of injection. Method of measurement: Clinical evaluations, blood tests, MRI.