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Assessment of the Efficacy of Stromal Vascular Fraction Treatment for Knee Osteoarthritis

NCT04749758 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2022-12-09

No results posted yet for this study

Summary

One-year follow-up prospective observational study involving male and female patients (over 18-years-old) with unilateral or bilateral knee osteoarthritis treated with intraarticular injection of stromal vascular fraction (SVF) treatment. Clinical, biological and radiological data before the treatment and 1-month, 6-month and a year after are collected.

The research hypothesis supports that SVF treatment enhance functionality and quality of live, relieves pain and improves magnetic resonance images of joint cartilage in patients with knee osteoarthritis.

Conditions

Interventions

BIOLOGICAL

SVF treatment

SVF treatment is developed by Cellab Laboratory (Celstem®). It is made following strict manufacturing guidelines and approved by Andorra's Government authorities. An abdominal fat liposuction is required to obtained Celstem®. The preparation of the product is carried out exclusively in a clean laboratory room under the conditions described by the AABB (American Association of Blood Banks) standards. The treatments application is carried out on the same day of the extraction, at some point between the next 6 hours from the end of the extraction. Firstly, ultrasound joint evaluation is performed. Under sterility measures, intraarticular infiltration of SVF treatment is performed at affected knee or knees. Previous synovial fluid aspiration is performed, if required. Once the procedure is completed, rehabilitation recommendations and clinical follow-up information is provided.

Sponsors & Collaborators

  • University of Andorra

    lead OTHER

Principal Investigators

  • Anna Boada-Pladellorens, MD · Hospital Nostra Senyora de Meritxell

  • Mercè Avellanet, PhD · Hospital Nostra Senyora de Meritxell

  • Esther Pages, PhD · Hospital Nostra Senyora de Meritxell

  • Josep A Farras Roca, MD · Cente mèdic d'especialitats Dr. Farras

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-20
Primary Completion
2022-12-07
Completion
2022-12-07

Countries

  • Andorra

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04749758 on ClinicalTrials.gov