Humerus Fracture Displaced ProximalPhase 1BMC2012NCT02153372
Cell Therapy by Bone Marrow-derived Mononuclear Cells (BMC) for Large Bone Defect Repair: Phase-I Clinical Trial
A Phase 1 study testing BMC2012 in people with Humerus Fracture Displaced Proximal, run by Goethe University at 1 site in Germany.
Trial summary
In the present phase-I clinical trial we investigate safety and feasibility of an augmentation with preoperatively isolated autologous BMC cells seeded onto ß-TCP in combination with an angle stable fixation (Philos plate®) for the therapy of proximal humeral fractures. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Humerus Fracture Displaced Proximal
- What is being tested?
- BMC2012
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2013to Sep 2014
- Phase
- Phase 1
- 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 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients aged between 50. and 90. years with proximal humerus fractures
- indication for open reposition and internal stabilisation with a proximal fixed- angle plate for humerus (PHILOS, Synthes, Oberdorf, Swiss):
- 2-, 3- or 4-fragment fracture according to NEer
- dislocation of >10 mm between fragments and/or
- angle of > 45° between fragments and/or
- dislocation of tuberculum major > 5 mm
- negative pregnancy test of premenopausal women
- signed informed consent for surgery and participation in the clinical trial
Who cannot join
- contraindications against administration of Investigational medicinal product (IMP) is pregnancy and nursing
- dislocation fracture
- known psychic disorder that leads to incompliance (e.g. dementia, schizophrenia, major depression)
- pathologic fractures caused by other underlying diseases
- fracture-induced nerve damage
- tumor disease with recent adjuvant therapy or treatment during the last 3 months (e.g. chemotherapy, radiotherapy), untreated tumor diseases
- known hypersensibility against components of the transplant
- participation in a clinical trial during the last 3 months prior to this study
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of trauma-, hand- and reconstructive surgery, Goethe University Hospital
Frankfurt, Theodor-Stern-Kai 7, 60590
About this study
Official title: Cell Based Therapy by Implanted Bone Marrow-derived Mononuclear Cells (BMC) for Bone Augmentation of Plate-stabilized Proximal Humeral Fractures
In the present phase-I clinical trial we investigate safety and feasibility of an augmentation with preoperatively isolated autologous BMC cells seeded onto ß-TCP in combination with an angle stable fixation (Philos plate®) for the therapy of proximal humeral fractures.
- Conditions
- Humerus Fracture Displaced Proximal
- Being tested
- BMC2012
- Keywords
- large bone defect, bone marrow-derived mononuclear cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMC2012Other
| Study group | Role | What they receive |
|---|---|---|
| BMC2012 | Experimental | The large bone defect was then be bridged as per clinical standard, filled with a clinically established scaffold (ß-TCP), and 1.3 x106/ml BMC were loaded per 1 ml ß-TCP in situ. Receives: Other: BMC2012 |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety
Analysis of safety : morbidity of bone marrow punction local reaction (infection, delayed wound healing) systemic reaction (leucocytes, C-reactive protein, Interleukin-6, procalcitonin) fever (> 38,5°C longer than 2 days)
Measured: at day -1
safety
Analysis of safety : morbidity of bone marrow punction local reaction (infection, delayed wound healing) systemic reaction (leucocytes, C-reactive protein, Interleukin-6, procalcitonin) fever (> 38,5°C longer than 2 days)
Measured: at day 0
safety
Analysis of safety : morbidity of bone marrow punction local reaction (infection, delayed wound healing) systemic reaction (leucocytes, C-reactive protein, Interleukin-6, procalcitonin) fever (> 38,5°C longer than 2 days)
Measured: week 1 post surgery
safety
Analysis of safety : morbidity of bone marrow punction local reaction (infection, delayed wound healing) systemic reaction (leucocytes, C-reactive protein, Interleukin-6, procalcitonin) fever (> 38,5°C longer than 2 days)
Measured: week 6 post surgery
safety
Analysis of safety : morbidity of bone marrow punction local reaction (infection, delayed wound healing) systemic reaction (leucocytes, C-reactive protein, Interleukin-6, procalcitonin) fever (> 38,5°C longer than 2 days)
Measured: week 12 post surgery
Secondary outcomes (5)
feasibility
Analysis of feasibility of isolation and application of BMC, logistic and clinical controls
Measured: at day-1
feasibility
Analysis of feasibility of isolation and application of BMC, logistic and clinical controls
Measured: at day 0
feasibility
Analysis of feasibility of isolation and application of BMC, logistic and clinical controls
Measured: week 1 post surgery
feasibility
Analysis of feasibility of isolation and application of BMC, logistic and clinical controls
Measured: week 6 post surgery
feasibility
Analysis of feasibility of isolation and application of BMC, logistic and clinical controls
Measured: week 12 post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2014 (estimated)
- Study startJul 2013
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Humerus Fracture Displaced ProximalStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Goethe University
- Sponsor type
- University, hospital or other
- Collaborators
- LOEWE CGT
- Responsible party
- Principal investigator, Ingo Marzi, MD Prof., Goethe University
- Investigators
- Ingo Marzi, MD Prof., Principal investigator, Department of Trauma-, hand- and reconstructive surgery, Goethe University, Frankfurt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02153372
- Sponsor's protocol ID
- BMC2012
- Acronym
- BMC2012
- Status last verified
- May 2016
- First submitted
- 13 Feb 2014
- Last updated
- 12 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cell Based Therapy by Implanted Bone Marrow-derived Mononuclear Cells (BMC) for Bone Augmentation of Plate-stabilized Proximal Humeral Fractures
- ClinicalTrials.gov ID
- NCT02153372
- Acronym / sponsor ID
- BMC2012 / BMC2012
- Conditions
- Humerus Fracture Displaced Proximal
- Keywords
- large bone defect, bone marrow-derived mononuclear cells
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Goethe UniversityUniversity, hospital or other
- Collaborators
- LOEWE CGT
- Study start
- Jul 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 3 Jun 2014 (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.
In the present phase-I clinical trial we investigate safety and feasibility of an augmentation with preoperatively isolated autologous BMC cells seeded onto ß-TCP in combination with an angle stable fixation (Philos plate®) for the therapy of proximal humeral fractures.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BMC2012 | Experimental | Other: BMC2012The large bone defect was then be bridged as per clinical standard, filled with a clinically established scaffold (ß-TCP), and 1.3 x106/ml BMC were loaded per 1 ml ß-TCP in situ. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- patients aged between 50. and 90. years with proximal humerus fractures
- indication for open reposition and internal stabilisation with a proximal fixed- angle plate for humerus (PHILOS, Synthes, Oberdorf, Swiss):
- 2-, 3- or 4-fragment fracture according to NEer
- dislocation of >10 mm between fragments and/or
- angle of > 45° between fragments and/or
Key exclusion criteria (8 listed)
- contraindications against administration of Investigational medicinal product (IMP) is pregnancy and nursing
- dislocation fracture
- known psychic disorder that leads to incompliance (e.g. dementia, schizophrenia, major depression)
- pathologic fractures caused by other underlying diseases
- fracture-induced nerve damage
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 |
|---|---|---|
| BMC2012 | Other | BMC2012 |
Primary outcome
safety
Time frame: at day -1
Analysis of safety : morbidity of bone marrow punction local reaction (infection, delayed wound healing) systemic reaction (leucocytes, C-reactive protein, Interleukin-6, procalcitonin) fever (> 38,5°C longer than 2 days)
safety
Time frame: at day 0
Analysis of safety : morbidity of bone marrow punction local reaction (infection, delayed wound healing) systemic reaction (leucocytes, C-reactive protein, Interleukin-6, procalcitonin) fever (> 38,5°C longer than 2 days)
safety
Time frame: week 1 post surgery
Analysis of safety : morbidity of bone marrow punction local reaction (infection, delayed wound healing) systemic reaction (leucocytes, C-reactive protein, Interleukin-6, procalcitonin) fever (> 38,5°C longer than 2 days)
safety
Time frame: week 6 post surgery
Analysis of safety : morbidity of bone marrow punction local reaction (infection, delayed wound healing) systemic reaction (leucocytes, C-reactive protein, Interleukin-6, procalcitonin) fever (> 38,5°C longer than 2 days)
safety
Time frame: week 12 post surgery
Analysis of safety : morbidity of bone marrow punction local reaction (infection, delayed wound healing) systemic reaction (leucocytes, C-reactive protein, Interleukin-6, procalcitonin) fever (> 38,5°C longer than 2 days)
5 secondary outcomes
feasibility
Time frame: at day-1
feasibility
Time frame: at day 0
feasibility
Time frame: week 1 post surgery
feasibility
Time frame: week 6 post surgery
feasibility
Time frame: week 12 post surgery
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 12 May 2016.
Related trials for Humerus Fracture Displaced Proximal
Active, not recruiting
The Nordic DeltaCon Trial for Displaced Proximal Humeral Fractures in Elderly
Proximal Humeral Fracture
Recruiting
Surgical Versus Non-surgical Treatment of Displaced Proximal Humerus Fracture in Adults Aged 50 to 65 Years
Proximal Humeral Fracture, Shoulder Fractures
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.
Ingo Marzi, MD Prof. principal investigator
Department of Trauma-, hand- and reconstructive surgery, Goethe University, Frankfurt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BMC2012 in people with Humerus Fracture Displaced Proximal, run by Goethe University at 1 site in Germany.
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 8 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 12 May 2016. 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 Germany. 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 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.
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?
safety (time frame: at day -1). The study lists 5 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 12 May 2016.