Treatment of patellofemoral osteoarthritis with nasal chondrocyte-based engineered cartilage implantation in a randomized, controlled, multi-center phase II clinical trial

Conditions

Patellofemoral osteoarthritis

Brief summary

Comparison of mean change in KOOS Pain from baseline to 24 months between groups (N-TEC – PRP > 15)

Detailed description

Mean KOOS Pain at 6 and 12 months, Mean KOOS subscales (Symptoms, Activity of daily living (ADL), Sports & Recreation (Sports), Quality of Life (QOL)) at 6, 12 and 24 months, Kujala Anterior Knee Pain Scale at 6, 12 and 24 months, WOMAC Score at 6, 12 and 24 months, EQ-5D-5L at 6, 12 and 24 months, VAS at 6, 12 and 24 months, Number of treatment failures and subjects non-responding (improvement in KOOS Pain < 13 on a scale of 0-100) at 24 months, Global Rating Of Change (GROC) likert scale at 6, 12 and 24 months, MARS at 6, 12 and 24 months, MRI Osteoarthritis Knee Score (MOAKS) for radiological evaluation of osteoarthritis at 6, 12 and 24 months, MRI of Cartilage Repair Tissue (MOCART) for radiological evaluation of repair tissue at 6, 12 and 24 months, Osteoarthritis grade according to Iwano and Kellgren/Lawrence classification at 6, 12 and 24 months, Number of SARs and SUSARs to assess safety

Sarina Seitz, G Lehoczky, Anke Wixmerten, Corina Schuster‐Amft, Sylvie Miot et al. (9 authors)

BMJ Open2025-08-011 citations

10.1136/bmjopen-2025-106140

Interventions

DRUGN-TEC

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Comparison of mean change in KOOS Pain from baseline to 24 months between groups (N-TEC – PRP > 15)	—

Secondary

Measure	Time frame
Mean KOOS Pain at 6 and 12 months, Mean KOOS subscales (Symptoms, Activity of daily living (ADL), Sports & Recreation (Sports), Quality of Life (QOL)) at 6, 12 and 24 months, Kujala Anterior Knee Pain Scale at 6, 12 and 24 months, WOMAC Score at 6, 12 and 24 months, EQ-5D-5L at 6, 12 and 24 months, VAS at 6, 12 and 24 months, Number of treatment failures and subjects non-responding (improvement in KOOS Pain < 13 on a scale of 0-100) at 24 months, Global Rating Of Change (GROC) likert scale at 6, 12 and 24 months, MARS at 6, 12 and 24 months, MRI Osteoarthritis Knee Score (MOAKS) for radiological evaluation of osteoarthritis at 6, 12 and 24 months, MRI of Cartilage Repair Tissue (MOCART) for radiological evaluation of repair tissue at 6, 12 and 24 months, Osteoarthritis grade according to Iwano and Kellgren/Lawrence classification at 6, 12 and 24 months, Number of SARs and SUSARs to assess safety	—

Measure

Time frame

Mean KOOS Pain at 6 and 12 months, Mean KOOS subscales (Symptoms, Activity of daily living (ADL), Sports & Recreation (Sports), Quality of Life (QOL)) at 6, 12 and 24 months, Kujala Anterior Knee Pain Scale at 6, 12 and 24 months, WOMAC Score at 6, 12 and 24 months, EQ-5D-5L at 6, 12 and 24 months, VAS at 6, 12 and 24 months, Number of treatment failures and subjects non-responding (improvement in KOOS Pain < 13 on a scale of 0-100) at 24 months, Global Rating Of Change (GROC) likert scale at 6, 12 and 24 months, MARS at 6, 12 and 24 months, MRI Osteoarthritis Knee Score (MOAKS) for radiological evaluation of osteoarthritis at 6, 12 and 24 months, MRI of Cartilage Repair Tissue (MOCART) for radiological evaluation of repair tissue at 6, 12 and 24 months, Osteoarthritis grade according to Iwano and Kellgren/Lawrence classification at 6, 12 and 24 months, Number of SARs and SUSARs to assess safety

—

Countries

Croatia, Germany

Outcome results

None listed