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Adipose-derived MSCs After Enzymatic Digestion vs. Mechanically Fragmented Fat Transfer in Knee Osteoarthritis Treatment

Sponsored by Medical University of Warsaw

About this trial

Last updated 5 years ago

Study ID

MSC

Status

Not yet recruiting

Type

Interventional

Phase

Phase 4

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 2 years ago

What is this trial about?

The aim of the study is to compare the clinical effects of treatment of knee osteoarthritis using adipose tissue mesenchymal stromal cells obtained by an enzymatic method with the outcomes of the therapy with the mechanically fragmented adipose tissue. Identification and functional analysis of the regenerative capacity of MSCs derived from the adipose tissue depending on three variables (body weight, sex and age) will help to develop a targeted therapy for different groups of patients and will determine the effectiveness of both methods of treatment. An attempt was made to identify the groups of patients with the greatest regeneration potential of the adipose tissue, and thus indicate those with the most probable improvement of the joint condition.

What are the participation requirements?

Yes

Inclusion Criteria

- Adults with symptomatic gonarthrosis diagnosed based on the X-ray, MRI and clinical examination, previously unsuccessfully treated (rehabilitation, NSAIDs, hyaluronic acid, platelet-rich plasma)

- Primary knee osteoarthritis

- Willingness and consent to participate in the study

- Readiness to attend control visits

No

Exclusion Criteria

- Failure to meet the inclusion criteria

- Active chronic infection

- Metal implant made of a ferromagnetic material that will exclude the patient from magnetic resonance imaging

- Use of anticoagulants

- General and intra-articular use of steroids during the last year

- Pregnancy, breastfeeding

- Any autoimmune and rheumatic disease, or conditions that influence the accuracy of test results

- Taking drugs or cytostatic medications in the last 30 days

- Mental disorders, alcohol and drug addiction