Clinical trial NCT01895413: Autologous Bone Marrow Mesenchymal Stem Cells Transplantation for Articular Cartilage Defects Repair
Official title: Autologous Bone Marrow-derived Mesenchymal Stem Cells Used in the Treatment of Articular Cartilage Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Osteoarthritis
Keywords: Cartilage injury
Osteoarthritis
Mesenchymal stem cells
Lead sponsor: Pontifícia Universidade Católica do Paraná
Sponsor class: OTHER
Collaborators: name: Pontifícia Universidade Católica do Paraná
name: Consultório Médico Dr. Alcy Vilas Boas Jr., Paraná, Brasil
name: Hospital Marcelino Champagnat, Paraná, Brasil
name: Fundação Araucária
First posted: 2013-07-10
Enrollment: 10
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in WOMAC (Western Ontario and McMaster Universities)score
timeFrame: 3 months, 6 months, 9 months, 12 months
Secondary outcomes:
measure: Change from baseline in cartilage thickness at 6 months by MRI
timeFrame: 6 months
measure: Knee pain relief (WOMAC and Lequesne scores)
timeFrame: 3 months, 6 months, 12 months
measure: Change from baseline in progression of osteoarthritis at 12 months by plain radiograph (X-ray)
timeFrame: 12 months
Other outcomes:
Locations:
city: Curitiba
country: Brazil
facility: Centro de Tecnologia Celular, Pontifícia Universidade Católica do Paraná
state: Paraná
Study officials:
affiliation: Pontifícia Universidade Católica do Paraná
name: Paulo Brofman, PhD
role: PRINCIPAL_INVESTIGATOR
References: