- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01895413
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
-
-
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
|
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.
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
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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