Brief Summary

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Official Title: "Effect of Bone Marrow-derived Mesenchymal Stem Cell Transplantation in Reconstructing Human Bone Defects"

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.

• Study Type: Interventional
• Study Design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Study Primary Completion Date: March 2011

Detailed Clinical Trial 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.

Interventions Used in this Clinical Trial

• Biological: cell injection
  • Injection of mesenchymal cells in fractured zone

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: non union
  • Patients with nonunion fracture of long bones

Outcome Measures for this Clinical Trial

Primary Measures

• Radiological progression of bone fusion
  • Time Frame: 3 months
    Safety Issue?: Yes

Secondary Measures

• Reduction of pain using VAS
  • Time Frame: 6 months
    Safety Issue?: Yes
• Cost analysis based on length of hospital stay
  • Time Frame: 6 months
    Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria

• Both genders are eligible
• Nonunion or delayed union diagnosed with X-Ray examination.
• More than 4 cm distance to joint
• Provided written informed consent

Exclusion Criteria

• Multiple major fracture or untreated major fracture
• Infected fracture
• HIV, hepatitis B or hepatitis C infection at the time of screening
• Pregnant or lactating women
• Diagnosis of cancer
• Active treatment with immunosuppressive drugs or anticoagulant agent
• Known allergic reaction to components of study treatment and/or study injection procedure

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 12 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

• Lead Sponsor
  • Royan Institute
• Provider of Information About this Clinical Study
  • Sponsor
• Overall Official(s)
  • Hamid Gourabi, PhD, Study Chair, President of Royan Institute
  • Mohammad reza Baghban Eslami Nejad, PhD, Study Director, Sientific Board
  • Mohssen Emadeddin, MD, Principal Investigator, Orthopadic Investigator
  • Nasser Aghdami, MD,PhD, Principal Investigator, Head of Regenerative center
  • Ahmad Vosough, MD, Principal Investigator, Radiologist investigator