Long Bone NonunionPhase 1/2NCT01581892
Use of Adult Bone Marrow Mononuclear Cells in Patients With Long Bone Nonunion
A Phase 1/2 study testing Osteosynthesis in people with Long Bone Nonunion, run by Hospital Universitario Central de Asturias at 1 site in Spain.
Trial summary
The aim of the study is to determine the safety and feasibility of autologous mononuclear stem cells in long bone nonunion; and moreover, to evaluate the efficacy of the treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Long Bone Nonunion
- What is being tested?
- Osteosynthesis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteSpain
- Study dates
- Dec 2011to Jan 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosed long bone nonunion
- age from 18 years old
Who cannot join
- active infection
- cancer patients
- concomitant serious illness
- pregnant women
- evidences of mental illness
- previous alcohol or drug dependences
- previous malignant disease during last 5 years, except for basal carcinoma
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, 33006
About this study
Official title: Treatment of Long Bone Nonunion With Autologous Bone Marrow Stem Cells. Phase I/II Study
The aim of the study is to determine the safety and feasibility of autologous mononuclear stem cells in long bone nonunion; and moreover, to evaluate the efficacy of the treatment.
Read the detailed description
In this study the investigators examine the improvement of conventional surgical treatment of long bone nonunion with the administration of bone marrow stem cells in order to achieve a higher percentage of healing and tissue reparation.
- Conditions
- Long Bone Nonunion
- Being tested
- Osteosynthesis
- Keywords
- bone nonunion, bone marrow, mononuclear, fracture
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OsteosynthesisProcedure or surgery
Also called bone nonunion, bone marrow, mononuclear, fracture
To mix the cell suspension with osteogenic matrix and to use sheet and nails in order to consolidate the fracture
| Study group | Role | What they receive |
|---|---|---|
| Bone marrow stem cells | Experimental | Bone marrow is obtained by posterosuperior iliac crest aspiration under topical anesthesia. Mononuclear cells were isolated by Ficoll density gradient and will be resuspended in heparinized isotonic saline for mixing with osteogenic matrix. Receives: Procedure: Osteosynthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absence of adverse effects during timeframe as infections or complications related with the intervention
The proposed trial will involve the recruitment of a total of 30 patients. The cells will be collected via bone marrow sampling. The aspirate will be centrifuged on a Ficoll density gradient to isolate mononuclear cells, wich will be resuspended in heparinized isotonic saline and used in order to infuse into the area surgically treated. The surgical intervention means the introduction of a sheet with nails according with the usually employed technique.
Measured: Six months
Secondary outcomes (1)
Improvement and union of the bone
The improvement of the bone nonunion will be assessed by X-ray and NMR
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2012 (estimated)
- Study startDec 2011
- Primary completionSep 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Long Bone NonunionStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Central de Asturias
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jesus Otero, MD, Principal investigator, Unidad de Coordinación de Trasplantes, Terapia Celular y Medicina Regenerativa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01581892
- Sponsor's protocol ID
- HUCA
- Status last verified
- Aug 2015
- First submitted
- 9 Apr 2012
- Last updated
- 25 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Fernandez-Bances I, Perez-Basterrechea M, Perez-Lopez S, Nunez Batalla D, Fernandez Rodriguez MA, Alvarez-Viejo M, Ferrero-Gutierrez A, Menendez-Menendez Y, Garcia-Gala JM, Escudero D, Paz Aparicio J, Carnero Lopez S, Lopez Fernandez P, Gonzalez Suarez D, Otero Hernandez J. Repair of long-bone pseudoarthrosis with autologous bone marrow mononuclear cells combined with allogenic bone graft. Cytotherapy. 2013 May;15(5):571-7. doi: 10.1016/j.jcyt.2013.01.004. Epub 2013 Feb 14.
PubMed 23415918
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Long Bone Nonunion With Autologous Bone Marrow Stem Cells. Phase I/II Study
- ClinicalTrials.gov ID
- NCT01581892
- Acronym / sponsor ID
- HUCA
- Conditions
- Long Bone Nonunion
- Keywords
- bone nonunion, bone marrow, mononuclear, fracture
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Hospital Universitario Central de AsturiasUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 20 Apr 2012 (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 aim of the study is to determine the safety and feasibility of autologous mononuclear stem cells in long bone nonunion; and moreover, to evaluate the efficacy of the treatment.
Detailed description
In this study the investigators examine the improvement of conventional surgical treatment of long bone nonunion with the administration of bone marrow stem cells in order to achieve a higher percentage of healing and tissue reparation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bone marrow stem cells | Experimental | Procedure: OsteosynthesisBone marrow is obtained by posterosuperior iliac crest aspiration under topical anesthesia. Mononuclear cells were isolated by Ficoll density gradient and will be resuspended in heparinized isotonic saline for mixing with osteogenic matrix. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- diagnosed long bone nonunion
- age from 18 years old
Key exclusion criteria (7 listed)
- active infection
- cancer patients
- concomitant serious illness
- pregnant women
- evidences of mental illness
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 |
|---|---|---|
| OsteosynthesisAlso: bone nonunion, bone marrow, mononuclear, fractureTo mix the cell suspension with osteogenic matrix and to use sheet and nails in order to consolidate the fracture | Procedure or surgery | Bone marrow stem cells |
Primary outcome
Absence of adverse effects during timeframe as infections or complications related with the intervention
Time frame: Six months
The proposed trial will involve the recruitment of a total of 30 patients. The cells will be collected via bone marrow sampling. The aspirate will be centrifuged on a Ficoll density gradient to isolate mononuclear cells, wich will be resuspended in heparinized isotonic saline and used in order to infuse into the area surgically treated. The surgical intervention means the introduction of a sheet with nails according with the usually employed technique.
1 secondary outcome
Improvement and union of the bone
Time frame: One year
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 25 Aug 2015.
- Background: PubMed 23415918Fernandez-Bances I, Perez-Basterrechea M, Perez-Lopez S, Nunez Batalla D, Fernandez Rodriguez MA, Alvarez-Viejo M, Ferrero-Gutierrez A, Menendez-Menendez Y, Garcia-Gala JM, Escudero D, Paz Aparicio J, Carnero Lopez S, Lopez Fernandez P, Gonzalez Suarez D, Otero Hernandez J. Repair of long-bone pseudoarthrosis with autologous bone marrow mononuclear cells combined with allogenic bone graft. Cytotherapy. 2013 May;15(5):571-7. doi: 10.1016/j.jcyt.2013.01.004. Epub 2013 Feb 14.
Related trials for Long Bone Nonunion
Enrolling by invitationObservational study
855303-RNA Biomarker Validation
Fractures, Bone
Recruiting
Bone Reconstruction With Autologous Bone Marrow Mesenchymal Stem Cells in Vitro to Repair Long Tubular Bone Defects
Defective Composite Restorations, Bone Cysts
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.
Jesus Otero, MD principal investigator
Unidad de Coordinación de Trasplantes, Terapia Celular y Medicina Regenerativa
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 Osteosynthesis in people with Long Bone Nonunion, run by Hospital Universitario Central de Asturias 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 2 inclusion and 7 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 25 Aug 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 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 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?
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?
Absence of adverse effects during timeframe as infections or complications related with the intervention (time frame: Six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01581892, which also lists 1 linked publication.
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 25 Aug 2015.