Femoral Neck FracturePhase 1/2NCT02630836
Allogeneic Mesenchymal Stromal Cells in Elderly Patients With Hip Fracture
A Phase 1/2 study testing XCEL-MT-OSTEO-BETA and Surgical treatment in people with Femoral Neck Fracture, run by Banc de Sang i Teixits.
Trial summary
Prospective, unicenter, randomized, open-label, single-dose, two-arms blinded assessor pilot study. Thirty-two (32) elderly patients with hip fracture will be randomized to one of the two treatment-arms (Xcel-MT-osteo-beta or Standard treatment) and be followed for 12 month with the primary objective of safety. Read more about this study
- Who is it for?
- Ages 70 to 85 years
- Conditions the study is for
- Femoral Neck Fracture
- What is being tested?
- XCEL-MT-OSTEO-BETA and Surgical treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2015to 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 70 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patient between70 and 85 years old
- Proximal femur fracture type 31A3 31a2 classification AO/ASIF.
- Deambulation prior to fracture.
- Written informed consent of the patient or family members.
Who cannot join
- Presence of implants at proximal femur level.
- Presence of local or systemic septic process.
- Septic arthritis.
- Dementia of any type.
- Hematological and biochemical analysis with significant alterations that contraindicate surgery.
- Patients with positive serology for HIV 1 and 2, Hepatitis B, Hepatitis C and syphilis.
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- Neoplastic disease detected in the last five years or without complete remission.
- Immunosuppressive status.
- Patients who received corticosteroids in the 3 months prior to study initiation.
- Simultaneous participation in another clinical trial or treatment with another investigational product within 3 months prior to inclusion in the study.
- Other conditions or circumstances that may compromise the patient's participation in the study according to medical criteria.
- Patient refusal to be followed by a period that may exceed the clinical trial itself.
About this study
Official title: A Pilot Clinical Trial of ex Vivo Expanded Allogenic Adult Stem Cells Combined With Allogenic Human Bone Tissue (XCEL-MT-OSTEO-BETA) in Proximal Femur Fractures in Elderly Patients
Prospective, unicenter, randomized, open-label, single-dose, two-arms blinded assessor pilot study. Thirty-two (32) elderly patients with hip fracture will be randomized to one of the two treatment-arms (Xcel-MT-osteo-beta or Standard treatment) and be followed for 12 month with the primary objective of safety. Secondary objectives are efficacy through axial tomography and xRay, clinical efficacy and quality of life questionnaire.
Read the detailed description
Prospective, unicenter, randomized, open-label, single-dose, two-arms blinded assessor phase I-II pilot study.
Thirty-two (32) elderly patients (70-85 years of age) with type 31A2 y 31A3 fracture of the femur (AO/ASIF (Association for the Study of Internal Fixation) classification) admitted at the emergency room of the Hospital Clinic of Barcelona will be randomized 1:1 to one of the two treatment-arms (endomedullary nailing + XCEL-MT-OSTEO-BETA or isolated endomedullary nailing as the standard treatment). Once surgically treated, patients will be followed for 12 month with the primary objective of safety. Secondary objectives are efficacy through axial tomography and xRay, clinical efficacy and quality of life questionnaire (EUROQOL-5D).
- Conditions
- Femoral Neck Fracture
- Being tested
- XCEL-MT-OSTEO-BETA, Surgical treatment
- Keywords
- mesenchymal stromal cells, stem cells, elderly, allogeneic, bone marrow, bone regeneration, fracture
- Medical subject headings
- Femoral Neck Fractures, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XCEL-MT-OSTEO-BETADrug
XCEL-MT-OSTEO-BETA followed by endomedullary nailing
Surgical treatmentProcedure or surgery
Isolated endomedullary nailing
| Study group | Role | What they receive |
|---|---|---|
| XCEL-MT-OSTEO-BETA | Experimental | Adult ex-vivo expanded mesenchymal stromal cells from allogeneic bone marrow, cryopreserved, to combine with fibrin glue and cancellous human bone tissue + endomedullary nailing Receives: Drug: XCEL-MT-OSTEO-BETA; Procedure: Surgical treatment |
| Standard treatment | Other | Standard surgical treatment with isolated endomedullary nailing Receives: Procedure: Surgical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety of XCEL-MT-OSTEO-BETA in proximal femur fractures by Adverse events, physical exam, laboratory tests.
Adverse events, physical exam, laboratory tests.
Measured: 12 months
Secondary outcomes (4)
efficacy through CT scan
assessment of consolidation by determination of Hounsfield units in CT scan
Measured: 3 months
efficacy through xRay
assessment of bone callus characteristics by standard radiology
Measured: 1, 3 and 6 months
efficacy by clinical assessment
Clinical assessment by visual analogue scale for pain
Measured: 1, 3 and 6 month
efficacy by quality of life questionnaire
EUROQoL-5D quality of life questionnaire
Measured: 3, 6 and 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionDec 2017 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoral Neck 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Banc de Sang i Teixits
- Sponsor type
- University, hospital or other
- Collaborators
- Fundacion Clinic per a la Recerca Biomédica
- Responsible party
- Sponsor
- Investigators
- Josep Maria Segur, MD, PhD, Principal investigator, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02630836
- Sponsor's protocol ID
- XCEL-MT-10-03
- Other IDs
- 2010-024041-78
- Status last verified
- Mar 2017
- First submitted
- 10 Dec 2015
- Last updated
- 17 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Clinical Trial of ex Vivo Expanded Allogenic Adult Stem Cells Combined With Allogenic Human Bone Tissue (XCEL-MT-OSTEO-BETA) in Proximal Femur Fractures in Elderly Patients
- ClinicalTrials.gov ID
- NCT02630836
- Acronym / sponsor ID
- XCEL-MT-10-03
- Conditions
- Femoral Neck Fracture
- Keywords
- mesenchymal stromal cells, stem cells, elderly, allogeneic, bone marrow, bone regeneration, fracture
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Banc de Sang i TeixitsUniversity, hospital or other
- Collaborators
- Fundacion Clinic per a la Recerca Biomédica
- Study start
- Dec 2015
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 15 Dec 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.
Prospective, unicenter, randomized, open-label, single-dose, two-arms blinded assessor pilot study. Thirty-two (32) elderly patients with hip fracture will be randomized to one of the two treatment-arms (Xcel-MT-osteo-beta or Standard treatment) and be followed for 12 month with the primary objective of safety. Secondary objectives are efficacy through axial tomography and xRay, clinical efficacy and quality of life questionnaire.
Detailed description
Prospective, unicenter, randomized, open-label, single-dose, two-arms blinded assessor phase I-II pilot study.
Thirty-two (32) elderly patients (70-85 years of age) with type 31A2 y 31A3 fracture of the femur (AO/ASIF (Association for the Study of Internal Fixation) classification) admitted at the emergency room of the Hospital Clinic of Barcelona will be randomized 1:1 to one of the two treatment-arms (endomedullary nailing + XCEL-MT-OSTEO-BETA or isolated endomedullary nailing as the standard treatment). Once surgically treated, patients will be followed for 12 month with the primary objective of safety. Secondary objectives are efficacy through axial tomography and xRay, clinical efficacy and quality of life questionnaire (EUROQOL-5D).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| XCEL-MT-OSTEO-BETA | Experimental | Drug: XCEL-MT-OSTEO-BETA, Procedure: Surgical treatmentAdult ex-vivo expanded mesenchymal stromal cells from allogeneic bone marrow, cryopreserved, to combine with fibrin glue and cancellous human bone tissue + endomedullary nailing |
| Standard treatment | Other | Procedure: Surgical treatmentStandard surgical treatment with isolated endomedullary nailing |
Who may qualify
- Ages
- 70 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Patient between70 and 85 years old
- Proximal femur fracture type 31A3 31a2 classification AO/ASIF.
- Deambulation prior to fracture.
- Written informed consent of the patient or family members.
Key exclusion criteria (12 listed)
- Presence of implants at proximal femur level.
- Presence of local or systemic septic process.
- Septic arthritis.
- Dementia of any type.
- Hematological and biochemical analysis with significant alterations that contraindicate surgery.
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 |
|---|---|---|
| XCEL-MT-OSTEO-BETAXCEL-MT-OSTEO-BETA followed by endomedullary nailing | Drug | XCEL-MT-OSTEO-BETA |
| Surgical treatmentIsolated endomedullary nailing | Procedure or surgery | Standard treatment, XCEL-MT-OSTEO-BETA |
Primary outcome
safety of XCEL-MT-OSTEO-BETA in proximal femur fractures by Adverse events, physical exam, laboratory tests.
Time frame: 12 months
Adverse events, physical exam, laboratory tests.
4 secondary outcomes
efficacy through CT scan
Time frame: 3 months
efficacy through xRay
Time frame: 1, 3 and 6 months
efficacy by clinical assessment
Time frame: 1, 3 and 6 month
efficacy by quality of life questionnaire
Time frame: 3, 6 and 12 month
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2017.
- Blood and Tissue Banc of CataloniaLink provided by the sponsor.
- Hospital Clínic de BarcelonaLink provided by the sponsor.
- Hospital Clinic FoundationLink 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.
Josep Maria Segur, MD, PhD principal investigator
Hospital Clinic of Barcelona
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing XCEL-MT-OSTEO-BETA and Surgical treatment in people with Femoral Neck Fracture, run by Banc de Sang i Teixits.
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 4 inclusion and 12 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: withdrawn, as of the sponsor's last update on 17 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
safety of XCEL-MT-OSTEO-BETA in proximal femur fractures by Adverse events, physical exam, laboratory tests. (time frame: 12 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 17 Mar 2017.