Autologous Bone Marrow Mesenchymal Stem Cells Transplantation for Articular Cartilage Defects Repair
Autologous Bone Marrow-derived Mesenchymal Stem Cells Used in the Treatment of Articular Cartilage Injury
1 other identifier
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Sep 2012
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2012
CompletedFirst Submitted
Initial submission to the registry
July 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedFirst Posted
Study publicly available on registry
July 10, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedDecember 13, 2017
October 1, 2015
10 months
July 1, 2013
December 11, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in WOMAC (Western Ontario and McMaster Universities)score
3 months, 6 months, 9 months, 12 months
Secondary Outcomes (3)
Change from baseline in cartilage thickness at 6 months by MRI
6 months
Knee pain relief (WOMAC and Lequesne scores)
3 months, 6 months, 12 months
Change from baseline in progression of osteoarthritis at 12 months by plain radiograph (X-ray)
12 months
Study Arms (1)
Mesenchymal stem cells
EXPERIMENTALBone marrow aspiration, Autologous bone marrow-derived mesenchymal stem cells
Interventions
Single intra-articular injection of autologous bone marrow-derived mesenchymal stem cells by arthroscopy
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alexandra Cristina Senegaglialead
- Pontifícia Universidade Católica do Paranácollaborator
- Consultório Médico Dr. Alcy Vilas Boas Jr., Paraná, Brasilcollaborator
- Hospital Marcelino Champagnat, Paraná, Brasilcollaborator
- Fundação Araucáriacollaborator
Study Sites (1)
Centro de Tecnologia Celular, Pontifícia Universidade Católica do Paraná
Curitiba, Paraná, 80215-901, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paulo Brofman, PhD
Pontifícia Universidade Católica do Paraná
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
July 1, 2013
First Posted
July 10, 2013
Study Start
September 1, 2012
Primary Completion
July 1, 2013
Study Completion
January 1, 2016
Last Updated
December 13, 2017
Record last verified: 2015-10