NCT05936060

Cartilage Recovery in Adults With Knee Osteorthritis by Mesenchymal Cell Therapy: Randomized Trial of Radiologic and Clinical Outcomes

Recovery of Joint Cartilage in Adults With Knee Osteoarthritis by Use of Mesenchymal Stromal Cells Derived From Human Umbilical Cord: Randomized Controlled Clinal Trial With Clinical and Radiologic Outcomes

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: GUSTAVO SALGUERO · Academic / Other
• Sex: All
• Age: 40 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The treatment of osteoarthritis (OA) of the knee remains still controversial. Despite that fact advanced stages with symptomatic and functional improvement are obtained with total knee replacement, however, there is no treatment that neither modifies the natural history of this disease, nor avoid joint replacement surgery in young patients in whom the prosthesis has conflictive indications. Moreover, prosthetic surgery leads to lower long-term survival and in older patients, higher morbidity and mortality. Cell therapy promises to be a treatment option through the use of mesenchymal cells with the capacity control inflammatory responses and trigger the differentiation into chondrocytes. Here we propose a randomized placebo-controlled clinical trial to evaluate radiologic and clinical outcomes in patients with knee OA.

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
BIOLOGICAL	INMUNOCEM	Mesenchymal Stromal Cell suspension intraarticularly injected
DRUG	PLACEBO COMPARATOR	Administration of plasmalyte as a vehicle for MSC

Timeline

• Start date: 2023-10-01
• Primary completion: 2026-07-31
• Completion: 2026-07-31
• First posted: 2023-07-07
• Last updated: 2023-07-07