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

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ClinicalTrials.gov Identifier: NCT01895413
Recruitment Status : Completed
First Posted : July 10, 2013
Last Update Posted : December 13, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Procedure: Bone marrow aspiration Phase 1 Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Autologous Bone Marrow-derived Mesenchymal Stem Cells Used in the Treatment of Articular Cartilage Injury
Study Start Date : September 2012
Primary Completion Date : July 2013
Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Mesenchymal stem cells
Bone marrow aspiration, Autologous bone marrow-derived mesenchymal stem cells
Procedure: Bone marrow aspiration
Single intra-articular injection of autologous bone marrow-derived mesenchymal stem cells by arthroscopy


Outcome Measures

Primary Outcome Measures :
  1. Change in WOMAC (Western Ontario and McMaster Universities)score [ Time Frame: 3 months, 6 months, 9 months, 12 months ]

Secondary Outcome Measures :
  1. Change from baseline in cartilage thickness at 6 months by MRI [ Time Frame: 6 months ]
  2. Knee pain relief (WOMAC and Lequesne scores) [ Time Frame: 3 months, 6 months, 12 months ]
  3. Change from baseline in progression of osteoarthritis at 12 months by plain radiograph (X-ray) [ Time Frame: 12 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01895413


Locations
Brazil
Centro de Tecnologia Celular, Pontifícia Universidade Católica do Paraná
Curitiba, Paraná, Brazil, 80215-901
Sponsors and Collaborators
Alexandra Cristina Senegaglia
Pontifícia Universidade Católica do Paraná
Consultório Médico Dr. Alcy Vilas Boas Jr., Paraná, Brasil
Hospital Marcelino Champagnat, Paraná, Brasil
Fundação Araucária
Investigators
Principal Investigator: Paulo Brofman, PhD Pontifícia Universidade Católica do Paraná
More Information

Responsible Party: Alexandra Cristina Senegaglia, PhD, Pontifícia Universidade Católica do Paraná
ClinicalTrials.gov Identifier: NCT01895413     History of Changes
Other Study ID Numbers: CTM_LESÃO ARTICULAR-461/2010
CTM_LESÃO ARTICULAR-461/2010 ( Other Grant/Funding Number: Fundação Araucária )
First Posted: July 10, 2013    Key Record Dates
Last Update Posted: December 13, 2017
Last Verified: October 2015

Keywords provided by Alexandra Cristina Senegaglia, Pontifícia Universidade Católica do Paraná:
Cartilage injury
Osteoarthritis
Mesenchymal stem cells

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases