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Friday, 02 March 2018 17:31

For the first time ever, arm and leg were healed using a bone graft grown outside patient’s body, in an orthopedic clinical trial for filling extensive critical bone void in limbs

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For the first time ever, arm and leg were healed using a bone graft grown outside patient’s body, in an orthopedic clinical trial for filling extensive critical bone void in limbs

logo4footerHaifa, March 11, 2018, Bonus BioGroup (TASE: BONS.TA), an Israeli biotechnology company engaged in personalized tissue engineering and cell therapy, and developing proprietary technology for growing live human bone grafts for implant in human patients, is pleased to announce that interim results for the first two months out of the twelve-month medical observation period for each patient participating in the clinical trial for filling extensive critical bone void in limbs – arm or leg, demonstrate that for the first time ever two patients have experienced forearm healing and another patient experienced thigh healing, within two months of implanting an injectable live bone graft manufactured by the Company.
Pursuant thereto, on March 8, 2018, all necessary approvals were obtained from the Ministry of Health and from the Haemek Medical Center, Afula, for conducting the clinical trial for filling orthopedic bone void in forty patients.
Injectable bone graft manufactured by Bonus BioGroup is grown outside of the patient’s body, at the Company’s manufacturing laboratory, based on the patient’s own adipose (fat) tissue-derived cells.
Implants in the arm or leg of each of the first three patients was performed by a team headed by Prof. Nimrod Rozen, head of orthopedics at Haemek Medical Center, Afula, according to an agreement between the Company and Clalit Health Services, Israel's largest HMO.
The clinical trial for filling orthopedic bone void is defined Phase I/II, with the clinical objectives of evaluating safety and efficacy of using the second generation of injectable bone graft for rehabilitating and healing extensive critical bone void in limbs – arm or leg, by filling the bone void using the second-generation injectable bone graft manufactured by Bonus BioGroup.
The clinical trial for filling orthopedic bone void is planned to include 30-40 participants, male and female, ages 18-75. In the first part of the trial, 10 participants shall be recruited for both clinical indications included in the trial, together; in the second part, at least 10 more participants shall be recruited for each of the two clinical indications and up to 30 additional participants for both clinical indications together.
The clinical trial for filling orthopedic bone void shall be conducted for two indications: (1) extensive critical bone void of long limb bone failing to mend, whether due to failure of the body's natural rehabilitation process without medical intervention, or in the event of failure of orthopedic procedure to mend the limb; and (2) long limb bone extra-articular comminuted fracture.
In a previous clinical trial, Bonus BioGroup achieved a revolutionary breakthrough in safe, rapid and efficient bone rehabilitation, through a single injection of live human bone graft, manufactured by the Company, which was successfully demonstrated in all participants of the Company's first clinical trial for repairing maxillofacial bone deficiencies in the upper or lower jaw, regardless of sex, age and medical background, recording a significance level of 95%.
Such extraordinary safety and efficacy results are not guaranteed by any other medical treatment. Demonstrating such high levels of statistical significance, even with a small sampling, means the success achieved is not coincidental, but rather is steadfast and repeatable, and therefore is expected to repeat itself also with a larger population.
Concurrently to conducting the first clinical trial, Bonus BioGroup has developed a second-generation injectable bone graft, which is more advanced, reduces manufacturing time, with less human involving, at a reduced cost and with suitability for mass production.
Currently, Bonus BioGroup is conducting two clinical trials for its second-generation injectable bone graft, both defined Phase I/II, with the clinical objectives of evaluating safety and efficacy of using its injectable bone graft, as follows:
1. In September 2016, a second clinical trial began for filling bone void in the upper or lower jawbone, administered by Dr. Ephraim Tzur;
2. In August 2017, a clinical trial began for filling critical bone voids in limbs – arm or leg, administered by Prof. Nimrod Rozen.
Bonus BioGroup strives to be the first company in the world to introduce to the global bone rehabilitation market, estimated at approximately US$7.5b per annum in 2017, a safe and rapid solution for filling bone deficiencies, through a single injection of live and expanding individual bone graft, manufactured by the Company after having been grown in the laboratory from cells sampled from the patient.
Alternate solutions considered for the first three patients, aside from using the injectable bone graft manufactured by Bonus BioGroup, were surgery for harvesting bone and peripheral blood vessels from another part of the body, and implanting them in the area of the void in arm or leg, or alternatively, using an artificial bone that shall not induce healing and not enable the patients to return to normal activity due to failure of artificial bone to bond with the human body.
Every patient desiring to participate in the clinical trial for filling bone voids using a live implant of human bone manufactured by Bonus BioGroup is required to undergo examinations to verify suitability for participating in the clinical trial.
Patients verified as being suitable for participating in the clinical trial undergo biopsy of fat tissue for deriving various cells necessary for manufacturing a live human bone graft for the patient, at Bonus BioGroup's manufacturing laboratory in Haifa, under controlled sterile conditions, on a three-dimensional scaffold and biodegradable scaffold carrier, in a unique environment simulating the conditions necessary for in vivo growth of human bone.
At Bonus BioGroup's manufacturing laboratory, fat tissue is separated into comprising cells that are divided into different types. While no use is made of fat cells, cells necessary for creating natural human bone are collected, from which the Company manufactures, within two weeks of sampling the patient's fat tissue, an injectable bone graft made of tiny bone grains, ready to be implanted in the patient's body.
Following the implant of injectable bone graft in the area of the void, the tiny grains of bone unite to become a firm bone, allowing for complete healing of the implant area.
Haemek Medical Center is one of the largest and most modern health centers in Israel, is fully associated with the Technion's Faculty of Medicine, and operated by Clalit Health Services, Israel's largest HMO providing medical services to more than 4.2 million individuals, which constitute a majority of the population of the State of Israel

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