Bone FracturePhase 2/3NCT02448849
Autologous BM-MSC Transplantation in Combination With Platelet Lysate (PL) for Nonunion Treatment
A Phase 2/3 study testing Percutaneous injection in people with Bone Fracture, run by Royan Institute at 1 site in Iran.
Trial summary
Nonunion of long bones would occur in almost 10% of fractures and because of its long term and complicated treatment, is known as a therapeutic challenge for both of the surgeons and patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bone Fracture
- What is being tested?
- Percutaneous injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIran
- Study dates
- Jun 2015to Aug 2017
- Phase
- Phase 2/3
- 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
- Non-united fracture of tibial midshaft at X-ray.
- Non-united gap less than 1cm.
- Fracture has fixed by closed intramedullary rod.
- Hypotrophic type.
- At least 6 months after initial surgery.
- Patient informed consent.
Who cannot join
- Infected nonunion
- Multiple major fracture
- Non treated major fracture
- malignancy
- Pregnancy or lactating
- Uncontrolled chronic diseases, such as: diabetes mellitus, hypertension, renal diseases, liver diseases, thyroid diseases, heart diseases, blood diseases, etc.
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- Steroid usage.
- Positive test for HIV and/or HBS and/or HBC and/or HTLV (1,2)
- Fracture site more than 1 cm.
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Royan Institute
Tehran
Nasser Aghdami, MD,PhD, (+98)23562000, nasser.aghdami@royaninstitute.org
Leila Arab, MD, (+98)23562000 ext. 414, Leara91@gmail.com
About this study
Official title: Use of Autologous Bone Marrow Derived Mesenchymal Stromal Cells in Combination With Platelet Lysate Product for Human Long Bone Nonunion Treatment, A Phase 2-3 Clinical Trial
Nonunion of long bones would occur in almost 10% of fractures and because of its long term and complicated treatment, is known as a therapeutic challenge for both of the surgeons and patients.
Cell therapy is useful in treatment of nonunion and mesenchymal stromal/stem cells are the best candidates for this kind of treatment.
Percutaneous implantation of autologous bone marrow derived mesenchymal stromal/stem cell in combination with PL will be done in 30 patients with tibia nonunion. The other 30 patients as the control group will receive placebo. The patients will be followed at 2weeks, 3months, 6m and 12 months after implantation.
The Spss(v16) software will be used for data analysis.
Read the detailed description
Long bone nonunion is known as a therapeutic challenge for both the orthopedic surgeons and the society. Current treatment of this disorder is autologous bone graft. This treatment has potential minor and major complications and is considered as a risky treatment. So researches are focused on new treatment approaches for this disease.
Cell therapy is one of these new approaches especially based on mesenchymal stromal cells.
The investigators will evaluate safety and efficacy of percutaneous implantation of autologous BM-MSC (bone marrow -derived mesenchymal stromal cell) in combination with PL (platelet lysate product) in 30 tibia nonunion patients. The other 30 patients will receive placebo. These patients will be followed up and data will be analyzed with spss(v16).
- Conditions
- Bone Fracture
- Being tested
- Percutaneous injection
- Keywords
- Autologous, nonunion fracture, bone marrow, mesenchymal, stromal cell, platelet lysate product
- Medical subject headings
- Fractures, Bone, Fractures, Ununited
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous injectionBiological
percutanous implantation of bone marrow derived mesenchymal stromal cells in patients with nonunion fracture.
Percutaneous injectionOther
Percutaneous implantation of placebo in patients with nonunion fracture.
| Study group | Role | What they receive |
|---|---|---|
| MSC recipients | Experimental | The patients with nonunion fracture who underwent percutaneous implantation of bone marrow derived mesenchymal stem cells in combination with platelet lysate product. Receives: Biological: Percutaneous injection |
| Placebo | Placebo comparator | The patients with nonunion fracture who underwent percutaneous injection of placebo. Receives: Other: Percutaneous injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical union
- Clinical union is defined as an asymptomatic patient who was able to fully bear weight on the injured leg
Measured: 3months
Radiological healing
- radiographic fracture healing is defined by bone continuity (bony bridging) present in three out of four cortices in two projections (anterior-posterior \& lateral x-rays), assessed by a blinded senior orthopedic surgeon.
CT scan, for confirm the results - radiolographic fracture healing is defined by bone continuity (bony bridging) present in three out of four cortices in two projections (anterior-posterior \& lateral x-rays), assessed by a blinded senior orthopedic surgeon.
CT scan, for confirm the results
- radiolographic fracture healing is defined by bone continuity (bony bridging) present in three out of four cortices in two projections (anterior-posterior \& lateral x-rays), assessed by a blinded senior orthopedic surgeon.
CT scan, for confirm the results
Measured: 1week
Secondary outcomes (3)
Pain
The pain relief as measured by Visual Analogue Scale (VAS) 3 months after cell injection
Measured: 3months
Quality of life
Evaluation the patients' quality of life with Visual Analogue Score (VAS) 3months after cell transplantation.
Measured: 3months
Walking distance
Walking distance changes as measured by walking on treadmill 3 months after cell injection.
Measured: 3months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2015 (estimated)
- Study startJun 2015
- Primary completionApr 2017 (estimated)
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
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 and cell therapy center of Royan InstituteMohammad Razi, MD, Study director, Department of orthopedic surgery, Tehran university of medical science, Tehran, IranMohsen Emadedin, MD, Principal investigator, Cell therapy center of Royan InstituteNarges Labibzadeh, MD, Principal investigator, Department of Regenerative Medicine and cell therapy center, Royan Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02448849
- Sponsor's protocol ID
- Royan-Bone-013
- Status last verified
- Sep 2015
- First submitted
- 5 May 2015
- Last updated
- 30 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Autologous Bone Marrow Derived Mesenchymal Stromal Cells in Combination With Platelet Lysate Product for Human Long Bone Nonunion Treatment, A Phase 2-3 Clinical Trial
- ClinicalTrials.gov ID
- NCT02448849
- Acronym / sponsor ID
- Royan-Bone-013
- Conditions
- Bone Fracture
- Keywords
- Autologous, nonunion fracture, bone marrow, mesenchymal, stromal cell, platelet lysate product
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Royan InstituteOther government
- Study start
- Jun 2015
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 20 May 2015 (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.
Nonunion of long bones would occur in almost 10% of fractures and because of its long term and complicated treatment, is known as a therapeutic challenge for both of the surgeons and patients.
Cell therapy is useful in treatment of nonunion and mesenchymal stromal/stem cells are the best candidates for this kind of treatment.
Percutaneous implantation of autologous bone marrow derived mesenchymal stromal/stem cell in combination with PL will be done in 30 patients with tibia nonunion. The other 30 patients as the control group will receive placebo. The patients will be followed at 2weeks, 3months, 6m and 12 months after implantation.
The Spss(v16) software will be used for data analysis.
Detailed description
Long bone nonunion is known as a therapeutic challenge for both the orthopedic surgeons and the society. Current treatment of this disorder is autologous bone graft. This treatment has potential minor and major complications and is considered as a risky treatment. So researches are focused on new treatment approaches for this disease.
Cell therapy is one of these new approaches especially based on mesenchymal stromal cells.
The investigators will evaluate safety and efficacy of percutaneous implantation of autologous BM-MSC (bone marrow -derived mesenchymal stromal cell) in combination with PL (platelet lysate product) in 30 tibia nonunion patients. The other 30 patients will receive placebo. These patients will be followed up and data will be analyzed with spss(v16).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MSC recipients | Experimental | Biological: Percutaneous injectionThe patients with nonunion fracture who underwent percutaneous implantation of bone marrow derived mesenchymal stem cells in combination with platelet lysate product. |
| Placebo | Placebo comparator | Other: Percutaneous injectionThe patients with nonunion fracture who underwent percutaneous injection of placebo. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Non-united fracture of tibial midshaft at X-ray.
- Non-united gap less than 1cm.
- Fracture has fixed by closed intramedullary rod.
- Hypotrophic type.
- At least 6 months after initial surgery.
Key exclusion criteria (9 listed)
- Infected nonunion
- Multiple major fracture
- Non treated major fracture
- malignancy
- Pregnancy or lactating
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 |
|---|---|---|
| Percutaneous injectionpercutanous implantation of bone marrow derived mesenchymal stromal cells in patients with nonunion fracture. | Biological | MSC recipients |
| Percutaneous injectionPercutaneous implantation of placebo in patients with nonunion fracture. | Other | Placebo |
Primary outcome
clinical union
Time frame: 3months
- Clinical union is defined as an asymptomatic patient who was able to fully bear weight on the injured leg
Radiological healing
Time frame: 1week
- radiographic fracture healing is defined by bone continuity (bony bridging) present in three out of four cortices in two projections (anterior-posterior \& lateral x-rays), assessed by a blinded senior orthopedic surgeon. CT scan, for confirm the results - radiolographic fracture healing is defined by bone continuity (bony bridging) present in three out of four cortices in two projections (anterior-posterior \& lateral x-rays), assessed by a blinded senior orthopedic surgeon. CT scan, for confirm the results - radiolographic fracture healing is defined by bone continuity (bony bridging) present in three out of four cortices in two projections (anterior-posterior \& lateral x-rays), assessed by a blinded senior orthopedic surgeon. CT scan, for confirm the results
3 secondary outcomes
Pain
Time frame: 3months
Quality of life
Time frame: 3months
Walking distance
Time frame: 3months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2015.
- Related InfoLink provided by the sponsor.
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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.
Hamid Gourabi, PhD study chair
Head of Royan Institute
Nasser Aghdami, MD,PhD study director
Head of Regenerative medicine department and cell therapy center of Royan Institute
Mohammad Razi, MD study director
Department of orthopedic surgery, Tehran university of medical science, Tehran, Iran
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Percutaneous injection in people with Bone 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 6 inclusion and 9 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 30 Oct 2015. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Nasser Aghdami, MD, PhD ((+98)23562000 ext. 516, nasser.aghdami@royaninstitute.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical union (time frame: 3months). The study lists 2 primary outcomes in all. 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 30 Oct 2015.