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OpenTrials
Completed

NCT Number: NCT01895413

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

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.

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Key information

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Centro de Tecnologia Celular, Pontifícia Universidade Católica do Paraná

Curitiba, Paraná, 80215-901, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bone Marrow Aspiration

Procedure

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

Primary outcomes

  1. Change in WOMAC (Western Ontario and McMaster Universities)score

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

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Alexandra Cristina Senegaglia

Other

Collaborators

  • Consultório Médico Dr. Alcy Vilas Boas Jr., Paraná, Brasil
  • Fundação Araucária
  • Hospital Marcelino Champagnat, Paraná, Brasil
  • Pontifícia Universidade Católica do Paraná

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2016
First posted
Jul 10, 2013
Registry last updated
Dec 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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