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Trial record 26 of 55 for:    stem cell arthritis AND stem cell transplantation

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01895413
Recruitment Status : Completed
First Posted : July 10, 2013
Last Update Posted : December 13, 2017
Sponsor:
Collaborators:
Pontifícia Universidade Católica do Paraná
Consultório Médico Dr. Alcy Vilas Boas Jr., Paraná, Brasil
Hospital Marcelino Champagnat, Paraná, Brasil
Fundação Araucária
Information provided by (Responsible Party):
Alexandra Cristina Senegaglia, Pontifícia Universidade Católica do Paraná

Tracking Information
First Submitted Date  ICMJE July 1, 2013
First Posted Date  ICMJE July 10, 2013
Last Update Posted Date December 13, 2017
Study Start Date  ICMJE September 2012
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 11, 2017)
Change in WOMAC (Western Ontario and McMaster Universities)score [ Time Frame: 3 months, 6 months, 9 months, 12 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 4, 2013)
Change in WOMAC (Western Ontário and MacMaster Universities)score [ Time Frame: 3 months, 6 months, 9 months, 12 months ]
Change History Complete list of historical versions of study NCT01895413 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 4, 2013)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Autologous Bone Marrow Mesenchymal Stem Cells Transplantation for Articular Cartilage Defects Repair
Official Title  ICMJE Autologous Bone Marrow-derived Mesenchymal Stem Cells Used in the Treatment of Articular Cartilage Injury
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis
Intervention  ICMJE Procedure: Bone marrow aspiration
Single intra-articular injection of autologous bone marrow-derived mesenchymal stem cells by arthroscopy
Study Arms  ICMJE Experimental: Mesenchymal stem cells
Bone marrow aspiration, Autologous bone marrow-derived mesenchymal stem cells
Intervention: Procedure: Bone marrow aspiration
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 4, 2013)
10
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2016
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01895413
Other Study ID Numbers  ICMJE CTM_LESÃO ARTICULAR-461/2010
CTM_LESÃO ARTICULAR-461/2010 ( Other Grant/Funding Number: Fundação Araucária )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alexandra Cristina Senegaglia, Pontifícia Universidade Católica do Paraná
Study Sponsor  ICMJE Alexandra Cristina Senegaglia
Collaborators  ICMJE
  • Pontifícia Universidade Católica do Paraná
  • Consultório Médico Dr. Alcy Vilas Boas Jr., Paraná, Brasil
  • Hospital Marcelino Champagnat, Paraná, Brasil
  • Fundação Araucária
Investigators  ICMJE
Principal Investigator: Paulo Brofman, PhD Pontifícia Universidade Católica do Paraná
PRS Account Pontifícia Universidade Católica do Paraná
Verification Date October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP