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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01895413

Enrollment

Registered

2013-07-10

Start date

2012-09-30

Completion date

2016-01-31

Last updated

2017-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis

Keywords

Cartilage injury, Osteoarthritis, Mesenchymal stem cells

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.

Interventions

PROCEDUREBone marrow aspiration

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

25 Years to 65 Years

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.

Design outcomes

Primary

Measure	Time frame
Change in WOMAC (Western Ontario and McMaster Universities)score	3 months, 6 months, 9 months, 12 months

Secondary

Measure	Time frame
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

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026