NCT03905824: OLT

The Effectiveness of Adding Allogenic Stem Cells After Traditional Treatment of Osteochondral Lesions of the Talus

Status unknown Phase 3 Last updated 9 April 2019

What this trial tests

Phase 3 trial testing Allogenic stromal mesenchymal cells derived from the umbilical cord in Osteochondral Fracture of Talus in 70 participants. Status unknown.

Timeline

15 January 2019

Primary endpoint
31 December 2020

31 December 2024

Quick facts

Lead sponsor	University of Chile
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	70
Start date	15 January 2019
Primary completion	31 December 2020
Estimated completion	31 December 2024
Sites	1 location across Chile

Drugs / interventions tested

• Allogenic stromal mesenchymal cells derived from the umbilical cord — full drug profile →
• Debridement and microfracture

Conditions studied

• Osteochondral Fracture of Talus — all drugs for Osteochondral Fracture of Talus →

Sponsor

University of Chile

Who can join

Adults 16 to 65, any sex, with Osteochondral Fracture of Talus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Randomized, multicentric, prospective, double-blind study: effectiveness of adding allogenic stem cells to a platelet-poor plasma scaffold after arthroscopic debridement and microfractures in patients with osteochondral lesions of the talus Osteochondral lesions of the talus (LOC), affects the ankle cartilage, which it seems to have less repair capacity than that of other joints such as the knee of the hip. The LOC can be an important source of pain and affects comparatively younger, working age and athletically active patients.

Although there are several therapeutic strategies, debridement and microfractures performed arthroscopically are the most frequent procedures. After this surgery, it is expected that fibrocartilage will form that covers the osteochondral lesion. Though good results have been reported, this fibrocartilage presents histological characteristics of lower quality to those of the native articular cartilage.

Based on previous studies in different joints, it is hypothesized that the augmentation treatment of osteochondral lesions of the talus with mesenchymal allogeneic stromal cells derived from the umbilical cord produces better clinical and imaging results than standard treatment with debridement and microfractures only.

Therefore, the present study seeks to compare the effectiveness of traditional debridement and microfracture treatment versus adding a platelet-poor plasma (PPP) scaffold embedded in allogeneic mesenchymal stromal cells derived from the umbilical cord in patients with osteochondral lesions of the talus.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Adult Stem Cells for Bone Regeneration and Repair.
   Iaquinta MR, Mazzoni E, Bononi I, Rotondo JC, et al · · 2019 · cited 176× · PMID 31799249 · DOI 10.3389/fcell.2019.00268
2. The Clinical Trials of Mesenchymal Stromal Cells Therapy.
   Kouchakian MR, Baghban N, Moniri SF, Baghban M, et al · · 2021 · cited 30× · PMID 34745268 · DOI 10.1155/2021/1634782
3. Implementation of Endogenous and Exogenous Mesenchymal Progenitor Cells for Skeletal Tissue Regeneration and Repair.
   Desai S, Jayasuriya CT. · · 2020 · cited 8× · PMID 32759659 · DOI 10.3390/bioengineering7030086