Allogenic mesenchymal stem cell intraarticular injection for knee osteoarthritis therapy, an RCT explorative mode-of-action study

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-506088-33-01

Enrollment

Registered

2024-02-16

Start date

2024-03-07

Completion date

Unknown

Last updated

2024-02-16

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

Conditions

knee osteoarthritis

Brief summary

Knee symptoms as evaluated by the Knee Injury and Osteoarthritis Score (KOOS), Pain diary (first 30 days after AD-MSC or placebo treatment), Adverse events will be collected the first year after AD-MSC or placebo treatment

Detailed description

Cartilage regeneration (MRI Osteoarthritis Knee Score), Quantitative MRI protocol, Pain as reported on the Numeric Rating Scale (NRS), Range of motion, Effusion tests (swelling), Knee diameter on the patellae (swelling), Atrophy (measure quadriceps muscle bulk 10 cm above the patellae top)

Interventions

DRUGMSC

DRUGadipose tissue

DRUGNatriumklorid ”B. Braun”

DRUGNatriumklorid Fresenius Kabi 9 mg/ml

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Knee symptoms as evaluated by the Knee Injury and Osteoarthritis Score (KOOS), Pain diary (first 30 days after AD-MSC or placebo treatment), Adverse events will be collected the first year after AD-MSC or placebo treatment	—

Secondary

Measure	Time frame
Cartilage regeneration (MRI Osteoarthritis Knee Score), Quantitative MRI protocol, Pain as reported on the Numeric Rating Scale (NRS), Range of motion, Effusion tests (swelling), Knee diameter on the patellae (swelling), Atrophy (measure quadriceps muscle bulk 10 cm above the patellae top)	—

Countries

Denmark

Outcome results

None listed

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