- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01958502
Evaluation the Treatment of Nonunion of Long Bone Fracture of Lower Extremities (Femur and Tibia) Using Mononuclear Stem Cells From the Iliac Wing Within a 3-D Tissue Engineered Scaffold
Because the rate of non union of long bone in lower extremities specially in tibia in this two last decade due to malnutrition and smoking and other risk factors was increased, so many patient in our country suffer from non union. On the other hand it seems that the use of the mesenchymal stem cells can irritate the union rate. Also for better result we used the mesenchymal stem cells with BMP2 in collagenic scaffold. The collagen has a osteoconductive effect and BMP2 and stem cells has a osteoinductive effect therefore this combination is useful in filling the gap in non union site and irritate the union rate.
Mesenchymal stem cell derived from iliac bone marrow after centrifuge with ficoll procedure. Then the investigators will follow the patient with monthly radiography and evaluate the callus volume and clinical union and any side effect of this treatment. Clinical union consider to relief pain in non union site and be stable in examination.
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: mohammad taghi peivandi, MD
- Phone Number: +989153143691
- Email: peivandimt@mums.ac.ir
Study Contact Backup
- Name: Amin razi, MD
- Phone Number: +989153118713
- Email: aminra61@gmail.com
Study Locations
-
-
Khorasan
-
Mashhad, Khorasan, Iran, Islamic Republic of
- Recruiting
- Emdai Kamyab Hospital
-
Contact:
- mohammad taghi peivandi, MD
- Phone Number: 989153143691
- Email: peivandimt@mums.ac.ir
-
Contact:
- amin razi, MD
- Phone Number: 989153118713
- Email: aminra61@gmail.com
-
Principal Investigator:
- bibi fatemeh kalalinia, PHD
-
Principal Investigator:
- hosein hoseinkhani, PHD
-
Principal Investigator:
- sara amel farzad, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Every patient with non union in the site of long bone fracture
- Age more than 18 and under 60 years old
- Fracture having no radiological callus after 6 months and absence of any hypertrophic bone reaction.
- No infection in site of surgery
- Be able and willing to participate in the study
- Written informed consent
Exclusion Criteria:
- Evidence of malignancy
- Pregnancy or breastfeeding
- Patient positive by serology or PCR for HIV, hepatitis B or C infection the patient with Accompanied fracture such as hip fracture that could not weight bearing
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: mesenchymal stem cell
stem cells drived from iliac bone marrow with centrifuge and ficoll method then implant in collagenic 3-D scaffold with BMP-2 and put in non union site by surgical approach under general or spinal anesthesia as deemed appropriate by the anesthetist.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
clinical and radiological union at 1 month to 6 months
Time Frame: 6 months
|
patients receiving Mesenchymal Stem Cells within a 3-D tissue engineered scaffold that develop a partial or complete callus at 1, 2, 3, 4 ,5 and 6 months evaluate with standard X-rays
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety of Mesenchymal Stem Cells injection in nonunion fractures. Follow-up for revealing any significant immediate or late adverse effects(infection,malignancy,local or systemic allergic reaction)
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: mohammad taghi peivandi, MD, Emdadi Kamyab Hospital
- Study Director: amin razi, MD, Emdadi Kamyab Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 910359
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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