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Evaluation and comparison of the efficacy of bone marrow-derived products in the treatment of osteoarthritis

Evaluation and comparison of the efficacy of autologous Bone Marrow-derived Products (BMA and BMAC) in the treatment of Osteoarthritis of the hip, knee and spine

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-6mp5qvc
Enrollment
Unknown
Registered
2025-10-28
Start date
2021-02-10
Completion date
Unknown
Last updated
2025-11-17

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

Conditions

Gonarthrosis

Interventions

This is a randomized, prospective, double-blind, six-arm clinical trial. A total of 60 patients with osteoarthritis (OA) will be selected for this study, including: a) 20 patients with knee osteoarthr
b) 20 patients with hip osteoarthritis
and c) 20 patients with spinal osteoarthritis. Within each osteoarthritis group, patients will be randomized using specific software to receive bone marrow (10 patients) or concentrated bone marrow (1

Sponsors

Instituto de Ensino Superior de Indaiatuba LTDA
Lead Sponsor
Instituto do Osso e da Cartilagem - IOC
Collaborator

Eligibility

Age
30 Years to 80 Years

Inclusion criteria

Inclusion criteria: Both sexes; aged between 30 and 80 years; and having diagnosed osteoarthritis and classified according to an X-ray report; patients with moderate to severe osteoarthritis (III and IV)

Exclusion criteria

Exclusion criteria: Presenting osteoathritis of another origin and/or another degree according to the classifications mentioned above; presenting systemic diseases such as diabetes; rheumatoid arthritis; axial deviation (varus higher than 5 degrees, valgus higher than 5 degrees); hematologic diseases; cardiovascular diseases; infections; and immunosuppression; patients undergoing anticoagulant or antiplatelet therapy; use of nonsteroidal anti-inflammatory drugs 5 days before each blood collection; and patients with a hemoglobin concentration below 11 mg/dL and platelet count below 150,000 mm³

Design outcomes

Primary

MeasureTime frame
We expect to see a reduction in pain assessed by the visual analog pain scale (VAS), improvement in the function of the joint verified through functional scores

Secondary

MeasureTime frame
An improvement in the function health quality evaluated through Short-Form-36 (SF-36)

Countries

Brazil

Contacts

Public ContactJosé Fabio Lana

Orthoregen - Ensino e Pesquisa Em Medicina Regenerativa do Aparelho Locomotor LTDA

josefabiolana@gmail.com+55 19 3017 - 4366

Outcome results

None listed

Source: REBEC (via WHO ICTRP)