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

Osteoarthritis Clinical Trial

Official title:

Autologous Bone Marrow-derived Mesenchymal Stem Cells Used in the Treatment of Articular Cartilage Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01895413
• Other study ID #: CTM_LESÃO ARTICULAR-461/2010
• Secondary ID: CTM_LESÃO ARTICU
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: July 1, 2013
• Last updated: December 11, 2017
• Start date: September 2012
• Est. completion date: January 2016

Study information

• Verified date: October 2015
• Source: Pontifícia Universidade Católica do Paraná
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: January 2016
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Procedure:
• Bone marrow aspiration
Single intra-articular injection of autologous bone marrow-derived mesenchymal stem cells by arthroscopy

Locations

Country	Name	City	State
Brazil	Centro de Tecnologia Celular, Pontifícia Universidade Católica do Paraná	Curitiba	Paraná

Sponsors (5)

Lead Sponsor	Collaborator
Alexandra Cristina Senegaglia	Consultório Médico Dr. Alcy Vilas Boas Jr., Paraná, Brasil, Fundação Araucária, Hospital Marcelino Champagnat, Paraná, Brasil, Pontifícia Universidade Católica do Paraná

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in WOMAC (Western Ontario and McMaster Universities)score		3 months, 6 months, 9 months, 12 months
Secondary	Change from baseline in cartilage thickness at 6 months by MRI		6 months
Secondary	Knee pain relief (WOMAC and Lequesne scores)		3 months, 6 months, 12 months
Secondary	Change from baseline in progression of osteoarthritis at 12 months by plain radiograph (X-ray)		12 months