Author/Authors :
Emadedin، Mohsen نويسنده Department of Regenerative Biomedicine, Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran , , Labibzadeh، Narges نويسنده Department of Regenerative Biomedicine, Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran , , Fazeli، Roghayeh نويسنده Department of Regenerative Biomedicine, Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran , , Mohseni، Fatemeh نويسنده Department of Regenerative Biomedicine, Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran , , Hosseini، Seyedeh Esmat نويسنده Department of Regenerative Biomedicine, Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran , , Moghadasali، Reza نويسنده , , Mardpour، Soura نويسنده Department of Regenerative Biomedicine, Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran , , Azimian، Vajiheh نويسنده Department of Regenerative Biomedicine, Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran , , Goodarzi، Alireza نويسنده Research Center, Iranian Blood Transfusion Organization , , Ghorbani Liastani، Maede نويسنده Department of Regenerative Biomedicine, Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran , , Bafghi، Ali Mirazimi نويسنده Department of Regenerative Biomedicine, Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran , , Baghaban Eslaminejad، Mohamadreza نويسنده Department of Regenerative Biomedicine, Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran , , Aghdami، Nasser نويسنده Department of Regenerative Biomedicine, Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran ,
Abstract :
Objective: Nonunion is defined as a minimum of a 9-month period of time since an injury
with no visibly progressive signs of healing for 3 months. Recent studies show that application
of mesenchymal stromal cells (MSCs) in the laboratory setting is effective for bone
regeneration. Animal studies have shown that MSCs can be used to treat nonunions. For
the first time in an Iranian population, the present study investigated the safety of MSC
implantation to treat human lower limb long bone nonunion.
Materials and Methods: It is a prospective clinical trial for evaluating the safety of using
autologus bone marrow derived mesenchymal stromal cells for treating nonunion. Orthopedic
surgeons evaluated 12 patients with lower limb long bone nonunion for participation in this
study. From these, 5 complied with the eligibility criteria and received MSCs. Under fluoroscopic
guidance, patients received a one-time implantation of 20-50×106 MSCs into the nonunion site.
All patients were followed by anterior-posterior and lateral X-rays from the affected limb, in addition
to hematological, biochemical, and serological laboratory tests obtained before and 1, 3, 6,
and 12 months after the implantation. Possible adverse effects that included local or systemic,
serious or non-serious, and related or unrelated effects were recorded during this time period.
Results: From a safety perspective, all patients tolerated the MSCs implantation during
the 12 months of the trial. Three patients had evidence of bony union based on the after
implantation X- rays.
Conclusion: The results have suggested that implantation of bone marrow-derived MSCs
is a safe treatment for nonunion. A double-blind, controlled clinical trial is required to assess
the efficacy of this treatment (Registration Number: NCT01206179).
