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

A

Alexandra Cristina Senegaglia

Status and phase

Completed
Phase 2
Phase 1

Conditions

Osteoarthritis

Treatments

Procedure: Bone marrow aspiration

Study type

Interventional

Funder types

Other

Identifiers

NCT01895413
CTM_LESÃO ARTICULAR-461/2010 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment

10 patients

Sex

All

Ages

25 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

10 participants in 1 patient group

Mesenchymal stem cells
Experimental group
Description:
Bone marrow aspiration, Autologous bone marrow-derived mesenchymal stem cells
Treatment:
Procedure: Bone marrow aspiration

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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