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

December 11, 2017 updated by: Alexandra Cristina Senegaglia

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

10

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Paraná
      • Curitiba, Paraná, Brazil, 80215-901
        • Centro de Tecnologia Celular, Pontifícia Universidade Católica do Paraná

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in WOMAC (Western Ontario and McMaster Universities)score
Time Frame: 3 months, 6 months, 9 months, 12 months
3 months, 6 months, 9 months, 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in cartilage thickness at 6 months by MRI
Time Frame: 6 months
6 months
Knee pain relief (WOMAC and Lequesne scores)
Time Frame: 3 months, 6 months, 12 months
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
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexandra Cristina Senegaglia

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (ACTUAL)

July 1, 2013

Study Completion (ACTUAL)

January 1, 2016

Study Registration Dates

First Submitted

July 1, 2013

First Submitted That Met QC Criteria

July 4, 2013

First Posted (ESTIMATE)

July 10, 2013

Study Record Updates

Last Update Posted (ACTUAL)

December 13, 2017

Last Update Submitted That Met QC Criteria

December 11, 2017

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTM_LESÃO ARTICULAR-461/2010 (OTHER_GRANT: Fundação Araucária)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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