Treatment of Non Union of Long Bone Fractures by Autologous Mesenchymal Stem Cell
Condition: Nonunion Fractures
MeSH terms: Fractures, Bone; Fractures, Ununited
Study type: Interventional
Phase: Phase 1

Summary: 
      Treatment of nonunion, delayed union and malunion fractures of long bones remains
      problematic. The definition of nonunion is a failure of the fracture to heal in six months in
      a patient in whom progressive repair had not been observed radiographically between the third
      and sixth month after the fracture. First of all good surgical techniques are stable
      immobilization must be obtained and local sepsis excluded. Then stimulation of the callus is
      required. Numerous techniques have been developed ranging from invasive interventions
      (including internal fixation with the use of bone graft or bone graft substitutes) to non
      invasive procedures (ultrasound and pulsed electromagnetic fields).

      Recently, autologous cell therapy was presented as an interesting approach. The concept of
      such therapies is based on the effect of stem cells presented in the bone marrow and able to
      be transformed in osteoblast cells. The purpose of this study is to find if mesenchymal stem
      cells can stimulate bone regeneration in nonunion and delayed union fractures to reduce later
      surgeries required to augment the healing process and to accelerate the time to healing.
    

Detailed description: 
      Treatment of nonunion, delayed union and malunion fractures of long bones remains
      problematic. The definition of nonunion is a failure of the fracture to heal in six months in
      a patient in whom progressive repair had not been observed radiographically between the third
      and sixth month after the fracture. Nonunion is a serious complication of a fracture,
      occurring in 2-10% of patients, as it is associated with high economic and health burden.
      Many cases are subsequently approached by multiple surgical and nonsurgical modalities.
      Various devices, under the name of "bone growth stimulators" have been used to enhance
      healing of the fracture. Recent studies, demonstrated the efficacy of mesenchymal stem cells
      in regeneration of bone and cartilage tissue. In this study percutaneous injection of
      mesenchymal stem cells to the site of fracture is performed as an outpatient procedure or
      during an operative exposure to evaluate its efficacy in enhancing bone regeneration. In the
      case of small size of bone gap, mesenchymal stem cells are injected into the callus of
      fracture site through an outpatient procedure under the guide of fluoroscopy. If there is a
      large bone gap, through a surgical management, mesenchymal stem cells seeded on bone matrix
      are placed at the site of fracture. Patients are followed by X-Ray examination 1,2,6, and 12
      months after treatment.
    

Intervention name(s): cell injection
Intervention type(s): Biological
Intervention description(s): Injection of mesenchymal cells in fractured zone
Other intervention name(s): Cell transplantation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: nonunion fracture bone formation pain relief