Skip to content

Efficacy of autologous bone marrow-derived mesenchymal stem cells seeded on a 3D scaffold in treatment of knee cartilage defects. A randomized, controlled, open-label, multi-centre clinical trial.

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-503486-32-00
Acronym
OA-orMSCp-01
Enrollment
40
Registered
2024-11-15
Start date
2021-02-04
Completion date
Unknown
Last updated
2025-05-10

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

Conditions

Knee Cartilage Defect

Brief summary

Lysholm knee function score, at 24 months post-operation (comparison of score changes between the study arms)., KOOS value, at 24 months post-operation (comparison of score changes between the study arms)., Pain according to VAS, at 24 months post-operation (comparison of score changes between the study arms)., X-ray and MRI evaluation, at 24 months post-operation.

Detailed description

Lysholm knee function score, at 3, 6 and 12 months post-operation., KOOS value, at 3 , 6 and 12 months post-operation., Pain according to VAS, at 6 weeks, 3, 6 and 12 months post-operation., X-ray and MRI evaluation, at 12 months post-operation., Adverse event profiles at 6 weeks, 3, 6, 12 and 24 months post-operation (comparison between the study arms).

Interventions

DRUGBiCure ortho MSCp

Sponsors

Bioinova a.s.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
Lysholm knee function score, at 24 months post-operation (comparison of score changes between the study arms)., KOOS value, at 24 months post-operation (comparison of score changes between the study arms)., Pain according to VAS, at 24 months post-operation (comparison of score changes between the study arms)., X-ray and MRI evaluation, at 24 months post-operation.

Secondary

MeasureTime frame
Lysholm knee function score, at 3, 6 and 12 months post-operation., KOOS value, at 3 , 6 and 12 months post-operation., Pain according to VAS, at 6 weeks, 3, 6 and 12 months post-operation., X-ray and MRI evaluation, at 12 months post-operation., Adverse event profiles at 6 weeks, 3, 6, 12 and 24 months post-operation (comparison between the study arms).

Countries

Czechia

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026