Local Transplantation of Mesenchymal Stromal Cells Is Safe and Could Alleviate Kienbock Disease’S Complications: A Clinical Trial Study Publisher



Sadri B¹ ; Labibzadeh N¹ ; Mirmorsali L¹ ; Ebrahimi M¹ ; Bagherifard A² ; Arab L¹ ; Aghdami N¹ ; Madani H¹ ; Maal AB¹ ; Karimi S¹ ; Mehrpour SR³ ; Emadedin M¹ ; Vosough M¹ Show Affiliations
Source: Cell Journal Published:2024

Abstract

Objective: Kienbock disease is a rare condition characterized by severe pain and restricted wrist movement. Various palliative methods have been proposed as therapeutic strategies for alleviating symptoms. Mesenchymal stromal cell transplantation has been suggested as an innovative and promising approach due to its potential for inducing regeneration and immunomodulation in the necrotic tissue. This study aims to evaluate the safety of autologous bone marrow derived mesenchymal stromal cells (BM-MSCs) transplantation after core decompression in Kienbock disease. Materials and Methods: In this phase I of an open-label clinical trial, three patients (one female and two males) with stage 2 Kienbock disease underwent autologous BM-MSCs transplantation following lunate core decompression. The patients were followed up for six months to assess safety as well as secondary clinical outcomes, including pain level, range of motion (ROM), and functional disability. Results: Safety of BM-MSCs injection following the core decompression was evaluated by recording post-treatment complications during the six-month follow-up. No adverse events (AEs) or severe AEs (SAEs) were reported, indicating that BM-MSCs injection after core decompression is a safe intervention. All patients showed a remarkable reduction in visual analog scale (VAS) scores and Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire scores, suggesting the therapeutic potential of this intervention. Moreover, an increase in the ROM indicated that BM-MSCs transplantation can improve wrist functionality. Additionally, radiographic assessments before and after cell infusion demonstrated a reduction in lunate sclerosis after six months of follow-up. Conclusion: The transplantation of autologous BM-MSCs following lunate core decompression seems to be a safe clinical intervention and may lead to pain relief in patients with Kienbock disease. Furthermore, this procedure may help prevent disease progression during the follow-up period (registration number: NCT02646007). © 2024 Royan Institute (ACECR). All rights reserved.