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

Phase 1

Completed

• Conditions: Osteoarthritis
• Interventions: Procedure: Bone marrow aspiration

• Registration Number: NCT01895413
• Lead Sponsor: Alexandra Cristina Senegaglia

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2012-09
• Primary Completion: 2013-07
• Study First Submitted: 2013-07-01
• Study First Submitted QC: 2013-07-04
• Study First Posted: 2013-07-10
• Status Verified: 2015-10
• Study Completion: 2016-01
• Last Update Submitted: 2017-12-11
• Last Update Posted: 2017-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mesenchymal stem cells	Bone marrow aspiration	Bone marrow aspiration, Autologous bone marrow-derived mesenchymal stem cells

Primary Outcome Measures

Name	Time	Method
Change in WOMAC (Western Ontario and McMaster Universities)score	3 months, 6 months, 9 months, 12 months

Secondary Outcome Measures

Name	Time	Method
Change from baseline in cartilage thickness at 6 months by MRI	6 months
Knee pain relief (WOMAC and Lequesne scores)	3 months, 6 months, 12 months
Change from baseline in progression of osteoarthritis at 12 months by plain radiograph (X-ray)	12 months

Trial Locations

Locations (1)

Centro de Tecnologia Celular, Pontifícia Universidade Católica do Paraná; 🇧🇷 Curitiba, Paraná, Brazil