Mesenchymal Stromal Cells Implantation in Combination with Platelet Lysate Product Is Safe for Reconstruction of Human Long Bone Nonunion
Authors: Narges Labibzadeh, Mohsen Emadedin, Roghayeh Fazeli, Fatemeh Mohseni, Seyedeh Esmat Hosseini, M.Sc., Reza Moghadassali, Ph.D., Soura Mardpour, Vajiheh Azimian, Maede Ghorbani Liastani, Ali Mirazimi Bafghi, Mohamadreza Baghban Eslaminejad,Nasser Aghdami
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Objective: Nonunion is defined as a minimum of 9 months since injury without any visible progressive
signs of healing for 3 months. Recent literature has shown that the application of mesenchymal
stromal cells is safe, in vitro and in vivo, for treating long bone nonunion. The present
study was performed to investigate the safety of mesenchymal stromal cell (MSC) implantation
in combination with platelet lysate (PL) product for treating human long bone nonunion.
Materials and Methods: In this case series clinical trial, orthopedic surgeons visited
eighteen patients with long bone nonunion, of whom 7 complied with the eligibility criteria.
These patients received mesenchymal stromal cells (20 million cells implanted once
into the nonunion site using a fluoroscopic guide) in combination with PL product. For
evaluation of the effects of this intervention all the patients were followed up by taking
anterior-posterior and lateral X-rays of the affected limb before and 1, 3, 6, and 12 months
after the implantation. All side effects (local or systemic, serious or non-serious, related or
unrelated) were observed during this time period.
Results: From a safety perspective the MSC implantation in combination with PL was
very well tolerated during the 12 months of the trial. Four patients were healed; based on
the control X- ray evidence, bony union had occurred.
Conclusion: Results from the present study suggest that the implantation of bone marrow-
derived MSCs in combination with PL is safe for the treatment of nonunion. A double
blind, controlled clinical trial is required to assess the efficacy of this treatment (Registration