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

Nonunion Fractures Clinical Trial

Official title:

Effect of Bone Marrow-derived Mesenchymal Stem Cell Transplantation in Reconstructing Human Bone Defects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01206179
• Other study ID #: Royan-Bone-004
• Status: Completed
• Phase: Phase 1
• First received: September 20, 2010
• Last updated: December 13, 2011
• Start date: March 2009
• Est. completion date: May 2011

Study information

• Verified date: June 2008
• Source: Royan Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics CommitteeIran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: May 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 75 Years

Eligibility

• 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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fractures, Bone
• Fractures, Ununited
• Nonunion Fractures

Intervention

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

Locations

Country	Name	City	State
Iran, Islamic Republic of	Royan Institute	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Royan Institute

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiological progression of bone fusion	callus formation in fracture zone	3 months	Yes
Secondary	Reduction of pain using VAS	Patients feel less pain during use of fractured limb	6 months	Yes
Secondary	Cost analysis based on length of hospital stay	Cost benefit of cell transplantation by reduction of hospital admission time	6 months	No

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