Nonunion of FracturePhase 2NCT01958502
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
A Phase 2 study testing surgical treatment of non union with mesenchymal stem cells with BMP2 within a 3-D tissue engineered scaffold in people with Nonunion of Fracture, run by Emdadi Kamyab Hospital at 1 site in Iran.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Nonunion of Fracture
- What is being tested?
- surgical treatment of non union with mesenchymal stem cells with BMP2 within a 3-D tissue engineered scaffold
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteIran
- Study dates
- Jul 2013to Nov 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Emdai Kamyab Hospital
Mashhad, Khorasan
mohammad taghi peivandi, MD, 989153143691, peivandimt@mums.ac.ir
amin razi, MD, 989153118713, aminra61@gmail.com
About this study
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.
- Conditions
- Nonunion of Fracture
- Being tested
- surgical treatment of non union with mesenchymal stem cells with BMP2 within a 3-D tissue engineered scaffold
- Keywords
- nonunion, mesenchymal stem cell, scaffold, BMP2, long bone
- Medical subject headings
- Fractures, Ununited
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgical treatment of non union with mesenchymal stem cells with BMP2 within a 3-D tissue engineered scaffoldGenetic
| Study group | Role | What they receive |
|---|---|---|
| mesenchymal stem cell | Experimental | 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. Receives: Genetic: surgical treatment of non union with mesenchymal stem cells with BMP2 within a 3-D tissue engineered scaffold |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical and radiological union at 1 month to 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
Measured: 6 months
Secondary outcomes (1)
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)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2013 (estimated)
- Study startJul 2013
- Primary completionJul 2014 (estimated)
- Study completionNov 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonunion of FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emdadi Kamyab Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Taiwan University of Science and Technology
- Responsible party
- Principal investigator, mohammad taghi peivandi, Emdadi Kamyab Hospital
- Investigators
- mohammad taghi peivandi, MD, Principal investigator, Emdadi Kamyab Hospitalamin razi, MD, Study director, Emdadi Kamyab Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01958502
- Sponsor's protocol ID
- 910359
- Status last verified
- Oct 2013
- First submitted
- 21 Aug 2013
- Last updated
- 9 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01958502
- Acronym / sponsor ID
- 910359
- Conditions
- Nonunion of Fracture
- Keywords
- nonunion, mesenchymal stem cell, scaffold, BMP2, long bone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Emdadi Kamyab HospitalUniversity, hospital or other
- Collaborators
- National Taiwan University of Science and Technology
- Study start
- Jul 2013
- Primary completion
- Jul 2014 (estimated)
- Study completion
- Nov 2014 (estimated)
- First posted
- 9 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mesenchymal stem cell | Experimental | Genetic: surgical treatment of non union with mesenchymal stem cells with BMP2 within a 3-D tissue engineered scaffoldstem 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| surgical treatment of non union with mesenchymal stem cells with BMP2 within a 3-D tissue engineered scaffold | Genetic | mesenchymal stem cell |
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
mohammad taghi peivandi, MD principal investigator
Emdadi Kamyab Hospital
amin razi, MD study director
Emdadi Kamyab Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing surgical treatment of non union with mesenchymal stem cells with BMP2 within a 3-D tissue engineered scaffold in people with Nonunion of Fracture, run by Emdadi Kamyab Hospital at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact mohammad taghi peivandi, MD (+989153143691, peivandimt@mums.ac.ir), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical and radiological union at 1 month to 6 months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2013.