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

NCT ID: NCT01895413

Last Updated: 2017-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2016-01-31

Brief Summary

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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

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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.

Conditions

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Osteoarthritis

Keywords

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Cartilage injury Osteoarthritis Mesenchymal stem cells

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mesenchymal stem cells

Bone marrow aspiration, Autologous bone marrow-derived mesenchymal stem cells

Group Type EXPERIMENTAL

Bone marrow aspiration

Intervention Type PROCEDURE

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

Interventions

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Bone marrow aspiration

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pontifícia Universidade Católica do Paraná

OTHER

Sponsor Role collaborator

Consultório Médico Dr. Alcy Vilas Boas Jr., Paraná, Brasil

UNKNOWN

Sponsor Role collaborator

Hospital Marcelino Champagnat, Paraná, Brasil

UNKNOWN

Sponsor Role collaborator

Fundação Araucária

OTHER

Sponsor Role collaborator

Alexandra Cristina Senegaglia

OTHER

Sponsor Role lead

Responsible Party

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Alexandra Cristina Senegaglia

PhD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Paulo Brofman, PhD

Role: PRINCIPAL_INVESTIGATOR

Pontifícia Universidade Católica do Paraná

Locations

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Centro de Tecnologia Celular, Pontifícia Universidade Católica do Paraná

Curitiba, Paraná, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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CTM_LESÃO ARTICULAR-461/2010

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CTM_LESÃO ARTICULAR-461/2010

Identifier Type: -

Identifier Source: org_study_id