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Enhancement of Bone Regeneration and Healing in the Extremities by the Use of Autologous BonoFill-II

Primary Purpose

Bone Fracture

Status

Unknown status

Phase

Phase 1

Locations

Israel

Study Type

Interventional

Intervention

BonoFill-II

About this trial

This is an interventional treatment trial for Bone Fracture focused on measuring Critical Gap, Comminuted Fracture, Extra-Articular

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Age is under 18 or above 80
A simple fracture manageable by one definitive treatment
Pregnant or lactating women
Patients with active infection anywhere in the body except in the injured bone site that is in question and needs osteogenic treatment.
Subjects with recorded medical history diseases such as heart diseases, renal failure.
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
Subjects that have a known scar healing problem (keloid formation).
Subjects treated with Bisphosphonate drugs
Oncology patients in treatment
Subjects who received chemotherapy or radiotherapy treatment in the past
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.

Sites / Locations

Emek Medical CenterRecruiting
Hillel YafeRecruiting
Carmel Medical CenterRecruiting
Rambam Health Campus
Meir Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention Arm

Arm Description

Clinical Interventions: 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. Xray Urine Test CT Liposuction - harvest of 50-300ml autologous adipose tissue from the subject's abdomen Single transplantation of Investigational Medicinal Product BonoFill-II into long bone extra-articular comminuted fracture or large bone defect/critical gap

Outcomes

Primary Outcome Measures

Number of subjects with treatment-emergent appearance of safety issues

Subjects will be followed-up for 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 Xray. Outcome measure will be reported in number of incidences. Results will be aggregated into one single value of each one of the safety issues, indicating the number of subjects displaying these treatment-related safety issues.

Secondary Outcome Measures

Bone continuity

Bone union will be assessed by Xray and confirmed by CT. Outcome measure will be reported by Results will be aggregated into one single value indicating the number of subjects displaying bone union/continuity.

Time to union

Time to bone union will be recorded. Outcome measure will be reported in months and weeks.

Weight bearing ability

clinical examination of weight bearing ability for lower extremities or coffee-cup weight bearing ability for upper extremities

Lack of pain at the surgical site

Clinical evaluated by movements of the joints above and below the surgical site area

Full Information

NCT ID

NCT03024008

First Posted

January 11, 2017

Last Updated

June 30, 2021

Sponsor

BonusBio Group Ltd

1. Study Identification

Unique Protocol Identification Number

NCT03024008

Brief Title

Enhancement of Bone Regeneration and Healing in the Extremities by the Use of Autologous BonoFill-II

Official Title

A Multicenter Study to Evaluate the Enhancement of Bone Regeneration and Healing in the Extremities by the Use of Autologous BonoFill-II

Study Type

Interventional

2. Study Status

Record Verification Date

June 2021

Overall Recruitment Status

Unknown status

Study Start Date

July 27, 2017 (Actual)

Primary Completion Date

June 2022 (Anticipated)

Study Completion Date

September 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

BonusBio Group Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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: 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 rate, measured radiographically by CT at 6 and 12 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bone Fracture

Keywords

Critical Gap, Comminuted Fracture, Extra-Articular

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intervention Arm

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

BonoFill-II

Intervention Description

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.

Primary Outcome Measure Information:

Title

Number of subjects with treatment-emergent appearance of safety issues

Description

Time Frame

Throughout the post-intervention 12-month follow-up

Secondary Outcome Measure Information:

Title

Bone continuity

Description

Time Frame

Starting 4-week follow-up and through to the end of the 12-month follow-up

Title

Time to union

Description

Time to bone union will be recorded. Outcome measure will be reported in months and weeks.

Time Frame

Starting 4-week follow-up and through to the end of the 12-month follow-up

Title

Weight bearing ability

Description

clinical examination of weight bearing ability for lower extremities or coffee-cup weight bearing ability for upper extremities

Time Frame

3, 6 and 12 months

Title

Lack of pain at the surgical site

Description

Clinical evaluated by movements of the joints above and below the surgical site area

Time Frame

3, 6 and 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: Age is under 18 or above 80 A simple fracture manageable by one definitive treatment Pregnant or lactating women Patients with active infection anywhere in the body except in the injured bone site that is in question and needs osteogenic treatment. Subjects with recorded medical history diseases such as heart diseases, renal failure. 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 Subjects that have a known scar healing problem (keloid formation). Subjects treated with Bisphosphonate drugs Oncology patients in treatment Subjects who received chemotherapy or radiotherapy treatment in the past 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Nimrod Rozen, MD, PhD

Phone

+972-4-649-4201

nimrod_rozen@hotmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Vered Kivity, PhD, MBA

Phone

+972-73-206-7103

veredki@bonus-bio.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nimrod Rozen, MD, PhD

Organizational Affiliation

Emek Medical Center, Afula, Israel

Official's Role

Principal Investigator

Facility Information:

Facility Name

Emek Medical Center

City

'Afula

ZIP/Postal Code

1834111

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nimrod Rozen, MD, PhD

Phone

04-6494201

nimrod_rozen@hotmail.com

Facility Name

Hillel Yafe

City

Hadera

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yaniv Yonay, MD

Phone

972-4-7744738

yanivy@hy.health.gov.il

First Name & Middle Initial & Last Name & Degree

Yaniv Yonay, MD

Facility Name

Carmel Medical Center

City

Haifa

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Benny Bernfeld, MD

Phone

972-4-8250506

bernfeld_benny@clalit.org.il

First Name & Middle Initial & Last Name & Degree

Benny Bernfeld, MD

Facility Name

Rambam Health Campus

City

Haifa

Country

Israel

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Doron Norman, MD, PhD

d_norman@rmc.gov.il

First Name & Middle Initial & Last Name & Degree

Doron Norman, MD, PhD

Facility Name

Meir Medical Center

City

Kfar Saba

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nissim Ohana, MD

Phone

972-9-7472502

ohanan@clalit.org.il

First Name & Middle Initial & Last Name & Degree

Nissim Ohana, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Enhancement of Bone Regeneration and Healing in the Extremities by the Use of Autologous BonoFill-II

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