Bone DefectsPhase 1/23-D-TEBENCT03103295
3D Tissue Engineered Bone Equivalent for Treatment of Traumatic Bone Defects
A Phase 1/2 study testing 3D-Tissue Engineered Bone Equivalent in people with Bone Defects, run by A.A. Partners, LLC at 1 site in Ukraine.
Trial summary
This study investigates safety and efficacy of traumatic bone defects treatment with use of 3D tissue engineered bone equivalent (3D-TEBE). The aim of this study is to evaluate 3D-TEBE transplantation as a safe and efficient treatment for patients with traumatic long bone defects of critical size. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Bone Defects
- What is being tested?
- 3D-Tissue Engineered Bone Equivalent
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUkraine
- Study dates
- 20 Nov 2015to 20 Dec 2018
- Phase
- Phase 1/2
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Age 18 to 60 years
- Patients with long bone defects of critical size of the traumatic genesis;
- Lack of consolidation of bone fragments for at least 9 months;
- At least two attempts to achieve bone consolidation using traditional methods of treatment;
- A negative pregnancy test at women of childbearing age;
- Confirmation of participation in the study by signing The Written Informed Consent, personally or through a responsible caretaker;
Who cannot join
- The infection in the area of bone defect;
- History of prior cancer;
- Diabetes;
- Severe chronic liver diseases or kidneys disease in history
- Pregnancy;
- The presence of vascular, endocrine and somatic pathology which has a direct impact on the osteoreparation;
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- Any other physical diseases in decompensation or subcompensation, or those that are rated as severe or moderate;
- Therapeutic issues or psychiatric disorders of a patient which would make the subject unsuitable to participate in this study or to complete it;
- Participation in another clinical trial.
Trial locations and contacts
1 site in 1 country.
Ukraine1 site
LIMITED LIABILITY COMPANY "A.A. PARTNERS" (Medical company ilaya®)
Kiev, 03115, 9, I. Kramskogo Str.
About this study
Official title: Safety and Efficacy Study of Traumatic Bone Defects Treatment With Use of 3D Tissue Engineered Equivalent.
This study investigates safety and efficacy of traumatic bone defects treatment with use of 3D tissue engineered bone equivalent (3D-TEBE).
The aim of this study is to evaluate 3D-TEBE transplantation as a safe and efficient treatment for patients with traumatic long bone defects of critical size.
Read the detailed description
This new method of critical sized long bone defects treatment is under clinical development. Treatment of critical sized bone defects is an actual clinical challenge. The "gold standard" in this case is autologous bone grafting. The method disadvantage is associated with limited donor bone resources. Based on our preliminary clinical trial positive results on use of autologous cultured bone marrow-derived multipotent mesenchymal stromal cells (BM-MSCs) in traumatology, our aim was to develop 3D tissue-engineered bone equivalent transplantation technology for restoration of critical sized bone defects. The proposed 3D-TEBE transplantation for bone defects of critical size treatment expecting to restore the bone integrity, form new bone tissue in a site of bone defect, and reduce the rehabilitation period of a patient.
The data obtained from this study will have practical implications for the treatment of reparative osteogenesis alterations and will be based on the principles of evidence-based medicine
- Conditions
- Bone Defects
- Being tested
- 3D-Tissue Engineered Bone Equivalent
- Keywords
- tissue engineering,, regeneration,, repair,, traumatic bone defects,, regenerative therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D-Tissue Engineered Bone EquivalentBiological
Also called Tissue-engineered bone-like construct transplantation
Administrated for operative delivery of 3D-Tissue Engineered Bone Equivalent
| Study group | Role | What they receive |
|---|---|---|
| 3D-Tissue Engineered Bone Equivalent | Experimental | Patients with bone defects of critical size of long bones
3D Tissue Engineered Bone Equivalent: allogeneic or xenogeneic partially demineralized bone matrix (DBM) and plasma-derived fibrin gel seeded with autologous cultured bone marrow-derived multipotent mesenchymal stromal cells (BM-MSCs), periosteal progenitor cells (PPCs), peripheral blood-derived endothelial progenitor cells (PB-EPCs). Receives: Biological: 3D-Tissue Engineered Bone Equivalent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic and MRI assessment in progression
Radiological and MRI progression of consolidation of bone fragments
Measured: 12 months +3 years following 3D Tissue Engineered Bone Equivalent grafting
Secondary outcomes (2)
Reduction of pain using VAS
Patients feel less pain during use of fractured limb
Measured: 6 months
Cost analysis based on length of hospital stay
Cost benefit of 3D-TEBE transplantation by reduction of hospital admission time
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 posted6 Apr 2017
- Study start20 Nov 2015
- Primary completion20 Dec 2018 (estimated)
- Study completion20 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone DefectsStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- A.A. Partners, LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Volodymyr M. Oksymets, MD,PhD,DSci, Principal investigator, LIMITED LIABILITY COMPANY "A.A. PARTNERS" (Medical company ilaya® ),
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03103295
- Sponsor's protocol ID
- MSC-P2-14
- Acronym
- 3-D-TEBE
- Status last verified
- May 2017
- First submitted
- 31 Mar 2017
- Last updated
- 11 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Study of Traumatic Bone Defects Treatment With Use of 3D Tissue Engineered Equivalent.
- ClinicalTrials.gov ID
- NCT03103295
- Acronym / sponsor ID
- 3-D-TEBE / MSC-P2-14
- Conditions
- Bone Defects
- Keywords
- tissue engineering,, regeneration,, repair,, traumatic bone defects,, regenerative therapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- A.A. Partners, LLCUniversity, hospital or other
- Study start
- 20 Nov 2015 (actual)
- Primary completion
- 20 Dec 2018 (estimated)
- Study completion
- 20 Dec 2018 (estimated)
- First posted
- 6 Apr 2017 (actual)
- 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 investigates safety and efficacy of traumatic bone defects treatment with use of 3D tissue engineered bone equivalent (3D-TEBE).
The aim of this study is to evaluate 3D-TEBE transplantation as a safe and efficient treatment for patients with traumatic long bone defects of critical size.
Detailed description
This new method of critical sized long bone defects treatment is under clinical development. Treatment of critical sized bone defects is an actual clinical challenge. The "gold standard" in this case is autologous bone grafting. The method disadvantage is associated with limited donor bone resources. Based on our preliminary clinical trial positive results on use of autologous cultured bone marrow-derived multipotent mesenchymal stromal cells (BM-MSCs) in traumatology, our aim was to develop 3D tissue-engineered bone equivalent transplantation technology for restoration of critical sized bone defects. The proposed 3D-TEBE transplantation for bone defects of critical size treatment expecting to restore the bone integrity, form new bone tissue in a site of bone defect, and reduce the rehabilitation period of a patient.
The data obtained from this study will have practical implications for the treatment of reparative osteogenesis alterations and will be based on the principles of evidence-based medicine
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 3D-Tissue Engineered Bone Equivalent | Experimental | Biological: 3D-Tissue Engineered Bone EquivalentPatients with bone defects of critical size of long bones 3D Tissue Engineered Bone Equivalent: allogeneic or xenogeneic partially demineralized bone matrix (DBM) and plasma-derived fibrin gel seeded with autologous cultured bone marrow-derived multipotent mesenchymal stromal cells (BM-MSCs), periosteal progenitor cells (PPCs), peripheral blood-derived endothelial progenitor cells (PB-EPCs). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age 18 to 60 years
- Patients with long bone defects of critical size of the traumatic genesis;
- Lack of consolidation of bone fragments for at least 9 months;
- At least two attempts to achieve bone consolidation using traditional methods of treatment;
- A negative pregnancy test at women of childbearing age;
Key exclusion criteria (9 listed)
- The infection in the area of bone defect;
- History of prior cancer;
- Diabetes;
- Severe chronic liver diseases or kidneys disease in history
- Pregnancy;
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 |
|---|---|---|
| 3D-Tissue Engineered Bone EquivalentAlso: Tissue-engineered bone-like construct transplantationAdministrated for operative delivery of 3D-Tissue Engineered Bone Equivalent | Biological | 3D-Tissue Engineered Bone Equivalent |
Primary outcome
Radiographic and MRI assessment in progression
Time frame: 12 months +3 years following 3D Tissue Engineered Bone Equivalent grafting
Radiological and MRI progression of consolidation of bone fragments
2 secondary outcomes
Reduction of pain using VAS
Time frame: 6 months
Cost analysis based on length of hospital stay
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2017.
- Volodymyr Oksymets, Dmytro Zubov, Roman Vasyliev, Anzhela Rodnichenko, Olga Gubar, Alena Zlatska, Vitaliy Oksymets. Tissue-engineered bone for traumatology and orthopedics: biotechnology aspects and clinical outcomes.//Absract book. Posters. 37th SICOTLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Volodymyr M. Oksymets, MD,PhD,DSci principal investigator
LIMITED LIABILITY COMPANY "A.A. PARTNERS" (Medical company ilaya® ),
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing 3D-Tissue Engineered Bone Equivalent in people with Bone Defects, run by A.A. Partners, LLC at 1 site in Ukraine.
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 11 May 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 Ukraine. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
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?
Radiographic and MRI assessment in progression (time frame: 12 months +3 years following 3D Tissue Engineered Bone Equivalent grafting). 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 11 May 2017.