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

NCT04749758 | Completed DMC

• 1 other identifier: UA003GRCSSS
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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

Knee Osteoarthritis

Keywords

knee osteoarthritis; regenerative medicine; mesenchymal stem cells; stromal vascular fraction

Outcome Measures

Primary Outcomes (1)

• Change from baseline knee pain measured with a Visual Analogue Scale (VAS) at 1 year

  Joint pain measured using the Visual Analogue Scale (VAS), which allows the patient to score from 0 to 10, 0 being that there is no pain, and 10 the worst pain imaginable.

  Pain is assessed pre-intervention and at one year of follow-up.

Secondary Outcomes (4)

• Change from baseline functionality measured with Knee Injury and Osteoarthritis Outcome Score (KOOS) at 1 year

  Functionality is assessed pre-intervention and at one year of follow-up.

• Change from baseline quality of life measured with SF-36 questionnaire at 1 year.

  Quality of life is assessed pre-intervention and at one year of follow-up.

• Change from baseline disability measured with WHODAS 2.0 questionnaire at 1 year.

  Disability is assessed pre-intervention and at one year of follow-up.

• Change from baseline joint cartilage characteristics measured with Magnetic Resonance Imaging at 1 year.

  Joint cartilage characteristics are assessed pre-intervention and at one year of follow-up.

Study Arms (1)

SVF treatment

EXPERIMENTAL

SVF treatment is developed by Cellab Laboratory (Celstem®). It is approved by Andorra's Government authorities.

Biological: SVF treatment

Interventions

SVF treatment BIOLOGICAL

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.

SVF treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female over 18 years of age patients affected from unilateral or bilateral symptomatic knee osteoarthritis (KOA), determined by the diagnostic criteria of the American College of Rheumatology. Any degree of the Kellgren and Lawrence classification for KOA is included. Patients included must have KOA symptoms more than 6 months. Symptomatology must remain despite having done conventional treatment for KOA.

You may not qualify if:

• Suspicion, diagnosis or history of active or recent joint infection (less than 6 months)
• Neurological deficit in the affected limb
• Pregnant or breastfeeding women
• Positive serology for hepatitis B, hepatitis C and / or HIV
• Magnetic resonance imaging without pathological alterations
• Knee infiltration with glucocorticoids, hyaluronic acid, platelet - rich plasma and / or other regenerative medicine therapies in the last 3 months.
• Medical conditions, including the diagnosis of oncological pathology or infectious and severe heart, kidney or liver disease, which contraindicate sedation or liposuction procedure.
• History or diagnosis of dementia or higher functions unpreserved, which interfere communication.
• Not having the necessary skills and / or electronic devices necessary (even their relatives or acquaintances, or they can not help them) to complete the online questionnaires.

Sponsors & Collaborators

• University of Andorra: lead

Study Sites (1)

CelularClinic

Les Escaldes, AD700, Andorra

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Anna Boada-Pladellorens, MD

  Hospital Nostra Senyora de Meritxell

  PRINCIPAL INVESTIGATOR

• Mercè Avellanet, PhD

  Hospital Nostra Senyora de Meritxell

  STUDY CHAIR

• Esther Pages, PhD

  Hospital Nostra Senyora de Meritxell

  STUDY CHAIR

• Josep A Farras Roca, MD

  Cente mèdic d'especialitats Dr. Farras

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: One-year prospective observational study of patients treated with stromal vascular fraction treatment for knee osteoarthritis

Study Record Dates

• First Submitted: February 5, 2021
• First Posted: February 11, 2021
• Study Start: September 20, 2018
• Primary Completion: December 7, 2022
• Study Completion: December 7, 2022
• Last Updated: December 9, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

AN (1)