Instant MSC Product accompanying Autologous Chondron Transplantation (IMPACT) for focal articular cartilage lesions of the knee; feasibility and safety

Instant MSC Product accompanying Autologous Chondron Transplantation (IMPACT) for focal articular cartilage lesions of the knee; feasibility and safety - IMPACT

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON37740

Enrollment

Registered

2012-04-16

Start date

2013-04-10

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

Cartilage defect/ lesion.

Interventions

One-stage surgery using the Instant MSC Product accompanying Autologous Chondron Transplantation (IMPACT)

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients aged 18-45 with a cartilage defect in the femoral condyle or trochlea sized 2-8 cm2

Exclusion criteria

Exclusion criteria: Patients with other dieases of the knee joint such as osteoarthritis, inflammatory disease (rheumatoid arthritis, metabolic joint disease, psoriasis and gout and septic arthritis), malalignment and patients with a prior total menisectomy.

Design outcomes

Primary

Measure	Time frame
The primary objective of this study is clinical safety. Therefore, the main study parameter will be newly developed, or worsening of, existing AEs (see section 8.2 for definitions). A full, per patient, description of each AE will be recorded including the nature, date and time of onset, date or resolution, determination of seriousness, severity, action taken, outcome and causality to study treatment. Specific AEs of interest (see section 8.2.4 for definition) will be filed in a similar manner as AEs using separate scoring forms. If indicated, tissue vigilance will be reported to the Transfusion Reaction in Patients (TRIP) National Hemovigilance Office.	—

Measure

Time frame

The primary objective of this study is clinical safety. Therefore, the main study parameter will be newly developed, or worsening of, existing AEs (see section 8.2 for definitions). A full, per patient, description of each AE will be recorded including the nature, date and time of onset, date or resolution, determination of seriousness, severity, action taken, outcome and causality to study treatment. Specific AEs of interest (see section 8.2.4 for definition) will be filed in a similar manner as AEs using separate scoring forms. If indicated, tissue vigilance will be reported to the Transfusion Reaction in Patients (TRIP) National Hemovigilance Office.

—

Secondary

Measure	Time frame
The secondary study parameter will be the clinical improvement and quality of life after 6, 12 and 18 months as measured with, subscales of, the KOOS and the EQ5D, respectively.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)