Tibial FracturePhase 2NCT02140528
Allogeneic Mesenchymal Stem Cell Transplantation in Tibial Closed Diaphyseal Fractures
A Phase 2 study testing Mesenchymal stem cell injection in people with Tibial Fracture, run by Royan Institute at 1 site in Iran.
Trial summary
This study is a case-control prospective, clinal trial to assess the safety and efficacy of the allogeneic adipose derived mesenchymal stem cell transplantation on the healing of recent tibial fracture in 40 patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tibial Fracture
- What is being tested?
- Mesenchymal stem cell injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteIran
- Study dates
- Aug 2013to Apr 2016
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 65 years
- The presence of tibial fracture based on X ray
- tibial fracture is limited to diaphysial
Who cannot join
- Addiction
- Pregnancy
- liver or kidney disease or uncontrolled diabetes or heart and lung disease
- immune deficiency
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation the Safety and Efficacy of Allogeneic Mesenchymal Stem Cell Transplantation in Tibial Closed Diaphyseal Fractures
This study is a case-control prospective, clinal trial to assess the safety and efficacy of the allogeneic adipose derived mesenchymal stem cell transplantation on the healing of recent tibial fracture in 40 patients.
Read the detailed description
In this study all eligible patients divided in 2 group.20 patients received allogeneic adipose derived mesenchymal stem cell in the fractured site (case group) and other patients received the placebo in the fractured site (control group) .
To assess the outcomes, we will evaluate the patients at 2, 6 weeks and 3, 6 months after transplantation by: X-ray, BMD , VAS and biochemical analysis with laboratory tests.
- Conditions
- Tibial Fracture
- Being tested
- Mesenchymal stem cell injection, Placebo
- Keywords
- Allogenic adipose derived mesenchymal stem cell tibial fracture
- Medical subject headings
- Tibial Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesenchymal stem cell injectionBiological
Also called stem cell transplantation
Injection of adipose derived mesenchymal stem cell in the site of tibia fracture .
PlaceboBiological
| Study group | Role | What they receive |
|---|---|---|
| Mesenchymal stem cell receipients | Experimental | Transplantation of allogenic adipose derived mesenchymal stem cells in patients with tibial fracture. Receives: Biological: Mesenchymal stem cell injection |
| Placebo | Placebo comparator | Placebo injection in the site of fracture in patients with tibia fracture. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with union after transplantation of mesenchymal stem cell in case group in comparison with control group
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2014 (estimated)
- Study startAug 2013
- Primary completionMar 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tibial 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royan Institute
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Hamid Gourabi, PhD, Study chair, Head of Royan InstituteNasser Aghdami, MD,PhD, Study director, Head of regenerative medicine department &cell therapy center of Royan InstituteMohsen Emaddedin, MD, Study director, Department or regenerative medicine of Royan Institute.Aziz Ahmadi, MD, Principal investigator, Scientific board of Iranian Orthopedic AssociationMaedeh Ghorbani, MD, Principal investigator, Department of Regenerative MedicineAfshin Farhadi, MD, Principal investigator, Scientific board of Iranian Orthopedic Association
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02140528
- Sponsor's protocol ID
- Royan-Bone-012
- Status last verified
- Apr 2017
- First submitted
- 14 May 2014
- Last updated
- 27 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation the Safety and Efficacy of Allogeneic Mesenchymal Stem Cell Transplantation in Tibial Closed Diaphyseal Fractures
- ClinicalTrials.gov ID
- NCT02140528
- Acronym / sponsor ID
- Royan-Bone-012
- Conditions
- Tibial Fracture
- Keywords
- Allogenic adipose derived mesenchymal stem cell tibial fracture
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Royan InstituteOther government
- Study start
- Aug 2013 (actual)
- Primary completion
- Mar 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 16 May 2014 (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.
This study is a case-control prospective, clinal trial to assess the safety and efficacy of the allogeneic adipose derived mesenchymal stem cell transplantation on the healing of recent tibial fracture in 40 patients.
Detailed description
In this study all eligible patients divided in 2 group.20 patients received allogeneic adipose derived mesenchymal stem cell in the fractured site (case group) and other patients received the placebo in the fractured site (control group) .
To assess the outcomes, we will evaluate the patients at 2, 6 weeks and 3, 6 months after transplantation by: X-ray, BMD , VAS and biochemical analysis with laboratory tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mesenchymal stem cell receipients | Experimental | Biological: Mesenchymal stem cell injectionTransplantation of allogenic adipose derived mesenchymal stem cells in patients with tibial fracture. |
| Placebo | Placebo comparator | Biological: PlaceboPlacebo injection in the site of fracture in patients with tibia fracture. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 to 65 years
- The presence of tibial fracture based on X ray
- tibial fracture is limited to diaphysial
Key exclusion criteria (4 listed)
- Addiction
- Pregnancy
- liver or kidney disease or uncontrolled diabetes or heart and lung disease
- immune deficiency
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 |
|---|---|---|
| Mesenchymal stem cell injectionAlso: stem cell transplantationInjection of adipose derived mesenchymal stem cell in the site of tibia fracture . | Biological | Mesenchymal stem cell receipients |
| Placebo | Biological | Placebo |
Primary outcome
Number of patients with union after transplantation of mesenchymal stem cell in case group in comparison with control group
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2017.
- Related InfoLink provided by the sponsor.
Related trials for Tibial Fracture
Not yet recruiting
Magnesium-Titanium Hybrid Intramedullary Nail System For Long Bone Fractures
Tibial Fracture, Femoral Fracture
Not yet recruiting
Magnesium Alloy Scaffold With Controlled Degradation for Periarticular Bone Defects
Periarticular Bone Defect, Proximal Humerus Fracture
RecruitingPhase 3
Antibiotic Cement Bead Pouch Versus Negative Pressure Wound Therapy
Open tíbia Fracture
Not yet recruiting
Personalized Weight-Bearing With Smart Crutch Tips After Surgery for Tibial Plateau Fractures
Tibial Plateau Fracture
Not yet recruiting
Outpatient Floor Pedal Bike Utilization
Femur Fracture, Tibia Fracture
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.
Hamid Gourabi, PhD study chair
Head of Royan Institute
Nasser Aghdami, MD,PhD study director
Head of regenerative medicine department &cell therapy center of Royan Institute
Mohsen Emaddedin, MD study director
Department or regenerative medicine of Royan Institute.
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 Mesenchymal stem cell injection in people with Tibial Fracture, run by Royan Institute 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 27 Apr 2017. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with union after transplantation of mesenchymal stem cell in case group in comparison with control group (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 27 Apr 2017.