drugset / Trial / NCT05288725

Mesenchymal Stem Cell Therapy for Knee Osteoarthritis

NCT05288725

Phase 1/2 Unknown 120 enrolled Next Generation Regenerative Medicine LLC
RandomizedParallel-groupDouble-blindTreatment

Summary

The study is a multicentered, randomized, double-blinded, placebo-controlled study conducted on the unilateral knee of 120 patients. The study compares the effectiveness of an injection of a mesenchymal stem cell preparation from autologous bone marrow aspirate (BMA) to a corticosteroid control for knee osteoarthritis. WOMAC, VAS pain scores, and MRI will be used for assessment. The study will be conducted at 3 sites in the United States.

Timeline

Start
2022-08
Primary completion
2024-06
Completion
2024-12

Drugs

EvaluationDrugModalityDoseRoute
Subject NGRM-001 Cell therapy Other
Comparator Triamcinolone Acetonide Other / unclassified Other
Comparator Ropivacaine Other / unclassified

Indications