- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01206179
Treatment of Non Union of Long Bone Fractures by Autologous Mesenchymal Stem Cell
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 Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
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Tehran, Iran, Islamic Republic of
- Royan Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
- 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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: non union
Patients with nonunion fracture of long bones
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Injection of mesenchymal cells in fractured zone
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Radiological progression of bone fusion
Time Frame: 3 months
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callus formation in fracture zone
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3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reduction of pain using VAS
Time Frame: 6 months
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Patients feel less pain during use of fractured limb
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6 months
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Cost analysis based on length of hospital stay
Time Frame: 6 months
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Cost benefit of cell transplantation by reduction of hospital admission time
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6 months
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: hamid gourabi, PhD, President of Royan Institute
- Study Director: Mohammad reza Baghban Eslami Nejad, PhD, Sientific Board
- Principal Investigator: Nasser Aghdami, MD,PhD, Head of Regenerative center
- Principal Investigator: Ahmad Vosough, MD, Radiologist investigator
Publications and helpful links
General Publications
- 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.
- 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.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Royan-Bone-004
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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