PseudoarthrosisPhase 2NCT01813188
Clinical Trial Based on the Use of Mononuclear Cells From Autologous Bone Marrow in Patients With Pseudoarthrosis
A Phase 2 study testing ABM seeded onto a porous TCP and DBM and autologous bone graft in people with Pseudoarthrosis, run by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia at 1 site in Spain.
Trial summary
The purpose of this clinical trial is to check the non-inferiority and lower morbidity of the use of bone marrow mononuclear cells seeded onto a porous matrix of calcium phosphate, for the consolidation of tibial bone defects (pseudoarthrosis), compared with autologous bone graft. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pseudoarthrosis
- What is being tested?
- ABM seeded onto a porous TCP and DBM and autologous bone graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2011to Jun 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pseudarthrosis of tibia established any cause with at least 9 months.
- The pseudarthrosis is not to show signs of healing in the last 3 months.
- The pseudarthrosis subsidiary should not be solely osteosynthesis treatment.
- Age between 18 and 75 years.
- Serology Human Immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV) negative.
- Negative pregnancy test in women of childbearing age.
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- Patient sufficient guarantees of adherence to protocol.
- Signature written informed consent before a witness
- Inability to understand the informed consent
Who cannot join
- Systemic infection.
- Septic pseudoarthrosis.
- Insufficient skin coverage at the site of nonunion.
- Vascular insufficiency in the affected limb.
- Pathological fracture.
- Concomitant psychiatric or neurological disease.
- Concurrent or prior malignancy treated with chemotherapy over a period of less than 1 year.
- Concomitant severe disease not well controlled.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital UniversitarioVirgen de la Arrixaca
El Palmar, Murcia, 30120
About this study
Official title: Phase II Clinical Trial of Tissue Engineering Based on the Use of Mononuclear Cells From Autologous Bone Marrow Seeded on Porous Tricalcium Phosphate Biomaterial in Patients With Pseudoarthrosis
The purpose of this clinical trial is to check the non-inferiority and lower morbidity of the use of bone marrow mononuclear cells seeded onto a porous matrix of calcium phosphate, for the consolidation of tibial bone defects (pseudoarthrosis), compared with autologous bone graft.
Read the detailed description
An estimated 10% of closed fractures and between 35-45% in cases of open fractures, are at risk of developing a delay in the process of consolidation or a complete failure of it (pseudoarthrosis) depending on location , severity of trauma on bone, soft tissue and vascular structures Some of these cases are refractory to all treatment methods available today, requiring numerous interventions with the potential risk for recurrent infections that they carry. For this reason, its treatment remains a challenge for the orthopedic surgeon.
Recent advances in knowledge of cellular and molecular biology related to the mechanism of bone repair and biomaterials science have been joined in a new discipline called tissue engineering, its implementation in clinical practice is being done so progressive.
Cell therapy based on the use of adult stem cells (MSCs) derived from autologous bone marrow, introduces new applications for the repair of fractures including pseudoarthrosis and avascular bone necrosis.
Its mechanism of action does not focus only on their local action, but also in the release of signaling molecules with autocrine and paracrine action through recruitment and activation of endogenous MSCs to osteoblastic differentiation and bone tissue regeneration.
On the other hand, the seeding of MSCs on biomaterials (natural or synthetic) is more effective, to facilitate adherence, proliferation and extracellular matrix production in the area where implanted.
Today, the investigators can say that there are experimental and clinical evidence supporting the effectiveness of the method.
The investigators have designed a phase II clinical trial to check the feasibility of this approach.
- Conditions
- Pseudoarthrosis
- Being tested
- ABM seeded onto a porous TCP and DBM, autologous bone graft
- Keywords
- Fractures, Bone, Stem Cells
- Medical subject headings
- Pseudarthrosis, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABM seeded onto a porous TCP and DBMProcedure or surgery
cells collection under sedation . 114 mL are obtained and processed through a ficoll gradient.
Autologous bone marrow (ABM) cells seeded onto a porous tricalcium phosphate ceramic (TCP) and demineralized bone matrix (DBM)
autologous bone graftProcedure or surgery
autologous bone graft
| Study group | Role | What they receive |
|---|---|---|
| ABM seeded onto a porous TCP and DBM | Experimental | ABM seeded onto a porous TCP and DBM Receives: Procedure: ABM seeded onto a porous TCP and DBM |
| autologous bone graft | Active comparator | autologous bone graft Receives: Procedure: autologous bone graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time needed to repair the focus of necrosis measured by pain radiography
Measured: Baseline and every 14 days up to 180 days
Secondary outcomes (6)
Pain scale
Measured: Baseline and every 14 days up to 180 days
Technical success
Understood as having been able to perform the implant of calcium phosphate matrix loaded with more than 100 million mononuclear cells
Measured: 6 months
Morbidity
Infection of extraction points Pathological fracture of the extraction area Muscle hernia Stress fracture Infection of focus repaired Rupture of the focus fixture repaired Appearance of secondary malignancies
Measured: 6 months
Absence of adverse events
Measured: 6 months
physical exploratory
Measured: Baseline and every 14 days up to 180 days
Analgesia Scale
Measured: Baseline and every 14 days up to 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2013 (estimated)
- Study startApr 2011
- Primary completionDec 2013
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PseudoarthrosisStudies 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
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
- Sponsor type
- University, hospital or other
- Collaborators
- Carlos III Health Institute, Hospital Universitario Virgen de la Arrixaca
- Responsible party
- Sponsor
- Investigators
- Luis Meseguer Olmo, MD,PhD, Principal investigator, Hospital Universitario Virgen de la Arrixaca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01813188
- Sponsor's protocol ID
- TCBO-PS
- Status last verified
- Mar 2014
- First submitted
- 22 Jun 2011
- Last updated
- 30 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Trial of Tissue Engineering Based on the Use of Mononuclear Cells From Autologous Bone Marrow Seeded on Porous Tricalcium Phosphate Biomaterial in Patients With Pseudoarthrosis
- ClinicalTrials.gov ID
- NCT01813188
- Acronym / sponsor ID
- TCBO-PS
- Conditions
- Pseudoarthrosis
- Keywords
- Fractures, Bone, Stem Cells
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Fundacion para la Formacion e Investigacion Sanitarias de la Region de MurciaUniversity, hospital or other
- Collaborators
- Carlos III Health Institute, Hospital Universitario Virgen de la Arrixaca
- Study start
- Apr 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 18 Mar 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.
The purpose of this clinical trial is to check the non-inferiority and lower morbidity of the use of bone marrow mononuclear cells seeded onto a porous matrix of calcium phosphate, for the consolidation of tibial bone defects (pseudoarthrosis), compared with autologous bone graft.
Detailed description
An estimated 10% of closed fractures and between 35-45% in cases of open fractures, are at risk of developing a delay in the process of consolidation or a complete failure of it (pseudoarthrosis) depending on location , severity of trauma on bone, soft tissue and vascular structures Some of these cases are refractory to all treatment methods available today, requiring numerous interventions with the potential risk for recurrent infections that they carry. For this reason, its treatment remains a challenge for the orthopedic surgeon.
Recent advances in knowledge of cellular and molecular biology related to the mechanism of bone repair and biomaterials science have been joined in a new discipline called tissue engineering, its implementation in clinical practice is being done so progressive.
Cell therapy based on the use of adult stem cells (MSCs) derived from autologous bone marrow, introduces new applications for the repair of fractures including pseudoarthrosis and avascular bone necrosis.
Its mechanism of action does not focus only on their local action, but also in the release of signaling molecules with autocrine and paracrine action through recruitment and activation of endogenous MSCs to osteoblastic differentiation and bone tissue regeneration.
On the other hand, the seeding of MSCs on biomaterials (natural or synthetic) is more effective, to facilitate adherence, proliferation and extracellular matrix production in the area where implanted.
Today, the investigators can say that there are experimental and clinical evidence supporting the effectiveness of the method.
The investigators have designed a phase II clinical trial to check the feasibility of this approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ABM seeded onto a porous TCP and DBM | Experimental | Procedure: ABM seeded onto a porous TCP and DBMABM seeded onto a porous TCP and DBM |
| autologous bone graft | Active comparator | Procedure: autologous bone graftautologous bone graft |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Pseudarthrosis of tibia established any cause with at least 9 months.
- The pseudarthrosis is not to show signs of healing in the last 3 months.
- The pseudarthrosis subsidiary should not be solely osteosynthesis treatment.
- Age between 18 and 75 years.
- Serology Human Immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV) negative.
Key exclusion criteria (8 listed)
- Systemic infection.
- Septic pseudoarthrosis.
- Insufficient skin coverage at the site of nonunion.
- Vascular insufficiency in the affected limb.
- Pathological fracture.
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 |
|---|---|---|
| ABM seeded onto a porous TCP and DBMcells collection under sedation . 114 mL are obtained and processed through a ficoll gradient. Autologous bone marrow (ABM) cells seeded onto a porous tricalcium phosphate ceramic (TCP) and demineralized bone matrix (DBM) | Procedure or surgery | ABM seeded onto a porous TCP and DBM |
| autologous bone graftautologous bone graft | Procedure or surgery | autologous bone graft |
Primary outcome
Time needed to repair the focus of necrosis measured by pain radiography
Time frame: Baseline and every 14 days up to 180 days
6 secondary outcomes
Pain scale
Time frame: Baseline and every 14 days up to 180 days
Technical success
Time frame: 6 months
Morbidity
Time frame: 6 months
Absence of adverse events
Time frame: 6 months
physical exploratory
Time frame: Baseline and every 14 days up to 180 days
Analgesia Scale
Time frame: Baseline and every 14 days up to 180 days
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 30 Mar 2017.
Related trials for Pseudoarthrosis
Recruiting
Diagnostic Interest of Bone Tomoscintigraphy in the Search for Cervical Pseudarthrosis
Cervical Pseudarthrosis
Active, not recruiting
Lumbar Fusion With Porous Versus Non-Porous Cages
Spinal Fusion, Lumbar Fusion
Recruiting
SPECT/CT Bone Scan Quantification Surgery
Pseudoarthrosis of Bone
Active, not recruitingObservational study
Collecting Bone Graft During Spinal Decompression and Posterolateral Lumbar Fusion to Better Define Bone Making Cells
Pseudarthrosis After Fusion or Arthrodesis
RecruitingPhase 3
A Study to Assess How Effective and Safe NVD003 is for Treating Patients With Congenital Pseudarthrosis of the Tibia.
Congenital Pseudarthrosis of Tibia
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.
Luis Meseguer Olmo, MD,PhD principal investigator
Hospital Universitario Virgen de la Arrixaca
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 ABM seeded onto a porous TCP and DBM and autologous bone graft in people with Pseudoarthrosis, run by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia at 1 site in Spain.
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 9 inclusion and 8 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 30 Mar 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 Spain. 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?
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?
Time needed to repair the focus of necrosis measured by pain radiography (time frame: Baseline and every 14 days up to 180 days). 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 Mar 2017.