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

NCT ID: NCT01206179

Last Updated: 2011-12-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2011-05-31

Brief 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.

Conditions

Nonunion Fractures

Keywords

nonunion fracture bone formation pain relief

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

non union

Patients with nonunion fracture of long bones

Group Type: EXPERIMENTAL

cell injection

Intervention Type: BIOLOGICAL

Injection of mesenchymal cells in fractured zone

Interventions

cell injection

Injection of mesenchymal cells in fractured zone

Intervention Type: BIOLOGICAL

Other Intervention Names

Cell transplantation

Eligibility 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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Royan Institute

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hamid Gourabi, PhD

Role: STUDY_CHAIR

President of Royan Institute

Mohammad reza Baghban Eslami Nejad, PhD

Role: STUDY_DIRECTOR

Sientific Board

Mohssen Emadeddin, MD

Role: PRINCIPAL_INVESTIGATOR

Orthopadic Investigator

Nasser Aghdami, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Head of Regenerative center

Ahmad Vosough, MD

Role: PRINCIPAL_INVESTIGATOR

Radiologist investigator

Locations

Royan Institute

Tehran, , Iran

Countries

Iran

References

Emadedin M, Labibzadeh N, Fazeli R, Mohseni F, Hosseini SE, Moghadasali R, Mardpour S, Azimian V, Goodarzi A, Ghorbani Liastani M, Mirazimi Bafghi A, Baghaban Eslaminejad M, Aghdami N. Percutaneous Autologous Bone Marrow-Derived Mesenchymal Stromal Cell Implantation Is Safe for Reconstruction of Human Lower Limb Long Bone Atrophic Nonunion. Cell J. 2017 Apr-Jun;19(1):159-165. doi: 10.22074/cellj.2016.4866. Epub 2016 Dec 21.

Reference Type: DERIVED

PMID: 28367426 (View on PubMed)

Labibzadeh N, Emadedin M, Fazeli R, Mohseni F, Hosseini SE, Moghadasali R, Mardpour S, Azimian V, Ghorbani Liastani M, Mirazimi Bafghi A, Baghaban Eslaminejad M, Aghdami N. Mesenchymal Stromal Cells Implantation in Combination with Platelet Lysate Product Is Safe for Reconstruction of Human Long Bone Nonunion. Cell J. 2016 Fall;18(3):302-309. doi: 10.22074/cellj.2016.4557. Epub 2016 Aug 24.

Reference Type: DERIVED

PMID: 27602311 (View on PubMed)

Related Links

http://www.royaninstitute.org

Related Info

Other Identifiers

Royan-Bone-004

Identifier Type: -

Identifier Source: org_study_id