Autologous Bone Marrow Mesenchymal Stem Cells Transplantation for Articular Cartilage Defects Repair

Alexandra Cristina Senegaglia10 enrolled

Overview

This is a non-randomized study aimed to determine the safety and efficacy of intra-articular injection of autologous bone marrow-derived mesenchymal stem cells in patients with knee articular cartilage defects.

Osteoarthritis is the most prevalent joint disease, create articular cartilage defects is a frequent cause of joint pain, functional loss, and disability. Osteoarthritis often becomes chronic, and conventional treatments seek to ameliorate pain or improve mobility. However, these treatments rarely modify the course of the disease.Recent studies cell-based have shown encouraging results in both animal studies and a few human case reports. We designed a study to assess the safety and efficacy of osteoarthritis treatment with intra-articular injection of autologous bone marrow-derived mesenchymal stem cells.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Osteoarthritis

Interventions

Bone marrow aspirationPROCEDURE

Single intra-articular injection of autologous bone marrow-derived mesenchymal stem cells by arthroscopy

Eligibility

Sex: ALLMin age: 25 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosed with mild to moderate osteoarthritis (visual analogue scale) * History of joint swelling, pain, stiffness, altered gait and loss of motion due to degenerative cartilage Exclusion Criteria: * Any past history of neoplasia and primary hematological disease * Autoimmune disease or the medical history * Systemic bone or cartilage disorders * Acute or chronic communicable diseases including Hepatitis B, Hepatitis C and HIV * Co-morbidity which the physician deems as a contraindication to stem cell transplantation and bone marrow biopsy * Evidence of infection or fractures in or around the joint * Contraindication to bone marrow aspiration * Deviation from the axial axis (varus or valgus) greater than 12 degrees.

Locations (1)

Centro de Tecnologia Celular, Pontifícia Universidade Católica do Paraná

Curitiba, Paraná, Brazil

Outcomes

Primary Outcomes

Change in WOMAC (Western Ontario and McMaster Universities)score

Time frame: 3 months, 6 months, 9 months, 12 months

Secondary Outcomes

Change from baseline in cartilage thickness at 6 months by MRI

Time frame: 6 months

Knee pain relief (WOMAC and Lequesne scores)

Time frame: 3 months, 6 months, 12 months

Change from baseline in progression of osteoarthritis at 12 months by plain radiograph (X-ray)

Time frame: 12 months

Data from ClinicalTrials.gov

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