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Treatment of Non Union of Long Bone Fractures by Autologous Mesenchymal Stem Cell

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Royan Institute
ClinicalTrials.gov Identifier:
NCT01206179
First received: September 20, 2010
Last updated: December 13, 2011
Last verified: June 2008
  Purpose

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.


Condition Intervention Phase
Nonunion Fractures
Biological: cell injection
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Bone Marrow-derived Mesenchymal Stem Cell Transplantation in Reconstructing Human Bone Defects

Resource links provided by NLM:


Further study details as provided by Royan Institute:

Primary Outcome Measures:
  • Radiological progression of bone fusion [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    callus formation in fracture zone


Secondary Outcome Measures:
  • Reduction of pain using VAS [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Patients feel less pain during use of fractured limb

  • Cost analysis based on length of hospital stay [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Cost benefit of cell transplantation by reduction of hospital admission time


Enrollment: 6
Study Start Date: March 2009
Study Completion Date: May 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: non union
Patients with nonunion fracture of long bones
Biological: cell injection
Injection of mesenchymal cells in fractured zone
Other Name: Cell transplantation

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.

  Eligibility

Ages Eligible for Study:   12 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01206179

Locations
Iran, Islamic Republic of
Royan Institute
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Royan Institute
Investigators
Study Chair: Hamid Gourabi, PhD President of Royan Institute
Study Director: Mohammad reza Baghban Eslami Nejad, PhD Sientific Board
Principal Investigator: Mohssen Emadeddin, MD Orthopadic Investigator
Principal Investigator: Nasser Aghdami, MD,PhD Head of Regenerative center
Principal Investigator: Ahmad Vosough, MD Radiologist investigator
  More Information

Additional Information:
No publications provided

Responsible Party: Royan Institute
ClinicalTrials.gov Identifier: NCT01206179     History of Changes
Other Study ID Numbers: Royan-Bone-004
Study First Received: September 20, 2010
Last Updated: December 13, 2011
Health Authority: Iran: Ethics Committee
Iran: Ministry of Health

Keywords provided by Royan Institute:
nonunion fracture bone formation pain relief

Additional relevant MeSH terms:
Fractures, Bone
Fractures, Ununited
Wounds and Injuries

ClinicalTrials.gov processed this record on November 25, 2014