Bone FracturePhase 1/2NCT03024008
Enhancement of Bone Regeneration and Healing in the Extremities by the Use of Autologous BonoFill-II
A Phase 1/2 study testing BonoFill-II in people with Bone Fracture, run by BonusBio Group Ltd at 6 sites in Israel.
Trial summary
The purpose of this clinical study is to evaluate the safety and the efficacy of BonoFill-II as an autologous bone-regenerating graft in the reconstruction of deficient bone in two clinical indications: 1. Long and short bone extra-articular comminuted fracture 2. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Bone Fracture
- What is being tested?
- BonoFill-II
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 6 sitesIsrael
- Study dates
- 27 Jul 2017to Jun 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Long and short bones extra articular comminuted fracture or
- Long and short bones extra and intra articular defect/gap or non union, incapable of self-regeneration
Who cannot join
- Age is under 18 or above 80
- A simple fracture manageable by one definitive treatment
- Pregnant or lactating women
- Patients with active infection that is in question and needs osteogenic treatment.
- More than 3 previous failed interventions at the surgical site
- History of advanced congestive heart failure or active acute myocardial infarction (AMI), renal failure (estimated GFR of <30 ml/min/1.73 m2 at screening), or hepatic disease (hepatic insufficiency classified as Child-Pugh B or C)
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- Diabetic subjects (HbA1c > 8)
- Subject treated currently with systemic steroids.
- Subjects with known autoimmune diseases, such as Addison's disease, Celiac disease - sprue (gluten-sensitive enteropathy), Dermatomyositis, Graves disease, Hashimoto's thyroiditis, Multiple sclerosis, Myasthenia gravis, Pernicious anemia, Reactive arthritis, Rheumatoid arthritis, Sjogren syndrome, Systemic lupus erythematosus.
- Subjects diagnosed with osteoporosis
- Chronic severe PVD (Peripheral Vascular Disease) subjects
- Post major vascular operation in the treated limb/s and above the surgical site (with or without Gore-Tex grafting)
- Subjects that have a known scar healing problem (keloid formation).
- Subjects treated with Bisphosphonate drugs
- Oncology patient or subjects who received chemotherapy or radiotherapy treatment in the past 12 months
- Immunocompromised condition from any reason, at screening
- Subjects participating in another clinical trial 30 days prior to and during the study period.
- Drug addicts and psychiatric patients patients incapable of giving consent.
- Subjects with a known history of any significant medical disorder, which in the investigator's judgment contraindicates the subject's participation
- Subjects with any known allergy for local/general anesthesia
- Positive serology for either HIV, hepatitis B or hepatitis C
- Abnormal clinically significant laboratory test and findings, as per the investigator's judgment
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Israel6 sites, 6 recruiting
- Recruiting
Emek Medical Center
Afula, 1834111
Nimrod Rozen, MD, PhD, 04-6494201, nimrod_rozen@hotmail.com
- Recruiting
Barzilai Medical Center
Ashkelon, 7830604
Omri Lubovski, MD, 972-8-6745034, omril@bmc.gov.il
- Recruiting
Hillel Yafe
Hadera
Yaniv Yonay, MD, 972-4-7744738, yanivy@hy.health.gov.il
Yaniv Yonay, MD
- Recruiting
Carmel Medical Center
Haifa
Benny Bernfeld, MD, 972-4-8250506, bernfeld_benny@clalit.org.il
Benny Bernfeld, MD
- Recruiting
Rambam Health Campus
Haifa
Doron Norman, MD, PhD, d_norman@rmc.gov.il
Doron Norman, MD, PhD
- Recruiting
Meir Medical Center
Kfar Saba
Nissim Ohana, MD, 972-9-7472502, ohanan@clalit.org.il
Nissim Ohana, MD
About this study
Official title: A Multicenter Study to Evaluate the Enhancement of Bone Regeneration and Healing in the Extremities by the Use of Autologous BonoFill-II
The purpose of this clinical study is to evaluate the safety and the efficacy of BonoFill-II as an autologous bone-regenerating graft in the reconstruction of deficient bone in two clinical indications:
- Long and short bone extra-articular comminuted fracture
- Long and short bones extra and intra articular defect /Gap or non-union, incapable of self-regeneration
Read the detailed description
Primary Endpoint:
Safety: to establish that the transplantation of BonoFill-II into bone defect/gap is safe under the following conditions:
- No treatment-related appearance of heterotrophic bone ossification
- No excessive bone formation at the transplantation sites
- No abnormalities in the treated sites
Efficacy: to establish that the transplantation of BonoFill-II into bone defect/gap is effective under the following conditions:
- Bone continuity, measured radiographically by CT at 6 and 12 months.
- Weight-bearing ability, assessed at 6 and 12 months.
- Conditions
- Bone Fracture
- Being tested
- BonoFill-II
- Keywords
- Critical Gap, Comminuted Fracture, Extra-Articular
- Medical subject headings
- Fractures, Bone, Fractures, Comminuted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BonoFill-IIBiological
Surgery will be performed under local or general anesthetics according to the Investigator's and anesthesiologist discretion.
A standard orthopedic approach will be made according to the fracture site.Then the transplantation of BonoFill-II into the fracture site and the fixation of the fracture by intramedullary nail or plate and screws or external fixator as required will be performed.
internal fixation (plate and screws and intramedullary nails) will not be routinely removed. External fixators will be removed upon achievement of satisfactory bone union.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Clinical Interventions:
1. Blood tests: complete blood count, full blood chemistry and biochemistry including phosphate, alkaline phosphatase, calcium, renal and liver function, and coagulation. Serology tests: HIV, Hepatitis B, Hepatitis C.
2. Xray
3. Urine Test
4. CT
5. Liposuction - harvest of 50-300ml autologous adipose tissue from the subject's abdomen
6. Single transplantation of Investigational Medicinal Product BonoFill-II into long bone extra-articular comminuted fracture or large bone defect/critical gap Receives: Biological: BonoFill-II |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary safety endpoint: Absence of treatment-emergent appearance of safety issues
Subjects demonstrating no appearance of heterotrophic bone ossification, excessive bone formation and/or any abnormalities in the treated site, in the proximal or distal joint by visual examination of the transplantation site and by X-ray and/or CT.
Measured: Throughout the post-intervention 12-month follow-up
Efficacy endpoint: Bone continuity
Bone union, as assessed by X-ray and CT. CT scans are performed 6 and 12 months post operation, to verify bone regeneration and complete bone continuity was achieved.
Measured: Starting 4-week follow-up and through to the end of the 12-month follow-up
Functional efficacy endpoint: Weight bearing ability
clinical examination of weight bearing ability for lower extremities or coffee-cup weight bearing ability for upper extremities. The physician assesses the functionality of the operated limb, by testing the patients ability to bear their weight when standing (in case of lower limb bone defect) or by coffee cup holding simulation (in case of upper limb bone defect).
Measured: The test is performed at 3, 6 and 12 months post operation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2017 (estimated)
- Study start27 Jul 2017
- Primary completionMar 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BonusBio Group Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nimrod Rozen, MD, PhD, Principal investigator, Emek Medical Center, Afula, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03024008
- Sponsor's protocol ID
- CP-BNS05
- Status last verified
- Aug 2025
- First submitted
- 11 Jan 2017
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Study to Evaluate the Enhancement of Bone Regeneration and Healing in the Extremities by the Use of Autologous BonoFill-II
- ClinicalTrials.gov ID
- NCT03024008
- Acronym / sponsor ID
- CP-BNS05
- Conditions
- Bone Fracture
- Keywords
- Critical Gap, Comminuted Fracture, Extra-Articular
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- BonusBio Group LtdIndustry (pharma, biotech, devices)
- Study start
- 27 Jul 2017 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 18 Jan 2017 (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 study is to evaluate the safety and the efficacy of BonoFill-II as an autologous bone-regenerating graft in the reconstruction of deficient bone in two clinical indications:
- Long and short bone extra-articular comminuted fracture
- Long and short bones extra and intra articular defect /Gap or non-union, incapable of self-regeneration
Detailed description
Primary Endpoint:
Safety: to establish that the transplantation of BonoFill-II into bone defect/gap is safe under the following conditions:
- No treatment-related appearance of heterotrophic bone ossification
- No excessive bone formation at the transplantation sites
- No abnormalities in the treated sites
Efficacy: to establish that the transplantation of BonoFill-II into bone defect/gap is effective under the following conditions:
- Bone continuity, measured radiographically by CT at 6 and 12 months.
- Weight-bearing ability, assessed at 6 and 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Biological: BonoFill-IIClinical Interventions: 1. Blood tests: complete blood count, full blood chemistry and biochemistry including phosphate, alkaline phosphatase, calcium, renal and liver function, and coagulation. Serology tests: HIV, Hepatitis B, Hepatitis C. 2. Xray 3. Urine Test 4. CT 5. Liposuction - harvest of 50-300ml autologous adipose tissue from the subject's abdomen 6. Single transplantation of Investigational Medicinal Product BonoFill-II into long bone extra-articular comminuted fracture or large bone defect/critical gap |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Long and short bones extra articular comminuted fracture or
- Long and short bones extra and intra articular defect/gap or non union, incapable of self-regeneration
Key exclusion criteria (22 listed)
- Age is under 18 or above 80
- A simple fracture manageable by one definitive treatment
- Pregnant or lactating women
- Patients with active infection that is in question and needs osteogenic treatment.
- More than 3 previous failed interventions at the surgical site
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 |
|---|---|---|
| BonoFill-IISurgery will be performed under local or general anesthetics according to the Investigator's and anesthesiologist discretion. A standard orthopedic approach will be made according to the fracture site.Then the transplantation of BonoFill-II into the fracture site and the fixation of the fracture by intramedullary nail or plate and screws or external fixator as required will be performed. internal fixation (plate and screws and intramedullary nails) will not be routinely removed. External fixators will be removed upon achievement of satisfactory bone union. | Biological | Intervention Arm |
Primary outcome
Primary safety endpoint: Absence of treatment-emergent appearance of safety issues
Time frame: Throughout the post-intervention 12-month follow-up
Subjects demonstrating no appearance of heterotrophic bone ossification, excessive bone formation and/or any abnormalities in the treated site, in the proximal or distal joint by visual examination of the transplantation site and by X-ray and/or CT.
Efficacy endpoint: Bone continuity
Time frame: Starting 4-week follow-up and through to the end of the 12-month follow-up
Bone union, as assessed by X-ray and CT. CT scans are performed 6 and 12 months post operation, to verify bone regeneration and complete bone continuity was achieved.
Functional efficacy endpoint: Weight bearing ability
Time frame: The test is performed at 3, 6 and 12 months post operation.
clinical examination of weight bearing ability for lower extremities or coffee-cup weight bearing ability for upper extremities. The physician assesses the functionality of the operated limb, by testing the patients ability to bear their weight when standing (in case of lower limb bone defect) or by coffee cup holding simulation (in case of upper limb bone defect).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Individual participant dataSharing planned: No
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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.
Nimrod Rozen, MD, PhD principal investigator
Emek Medical Center, Afula, Israel
6 sites 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 BonoFill-II in people with Bone Fracture, run by BonusBio Group Ltd at 6 sites in Israel.
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 22 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: looking for participants now, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Israel. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nimrod Rozen, MD, PhD (+972-4-649-4201, nimrod_rozen@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary safety endpoint: Absence of treatment-emergent appearance of safety issues (time frame: Throughout the post-intervention 12-month follow-up). The study lists 3 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 10 Dec 2025.