Osteoporosis fractures: Bonus BioGroup (Israel) graft autologous bones grown in the laboratory

Home"Anciens1"Osteoporosis fractures: Bonus BioGroup (Israel) graft autologous bones grown in the laboratory
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No it's not science fiction. Israeli society BioGroup Bonus announced at the end of December 2017 to have succeeded for the first time a transplant in the leg of a patient who was suffering from severe bone loss, graft manufactured in two weeks by BioGroup Bonus and grown in the laboratory from the patient's own adipose tissue-derived cells.

BioGroup Bonus is a biotechnology, tissue engineering and personalized cell therapy company that develops proprietary human bone graft culture technology for patients.

Previously, the patient, resident of a Kibbutz, had been operated twice on the tibia following a car accident. A metal fixation system of the bones had been placed,However, significant bone loss remained which prevented complete healing of the fracture, limiting activity and causing constant crushing of the remaining bone. The operation was carried out by Professor Nimrod Rozen, head of the Orthopedics department of the hospital Emek Afula, wholly affiliated with the Faculty of Medicine of Technion.

According to Dr. Nimrod Rozen, this new surgery can even help people who have osteoporosis, cancer patients or have had amputations. It could even be used to save precious centimeters for people with dwarfism.

Exams to participate in clinical trials

Patients selected for the clinical trial undergo biopsy of the adipose tissue. The manufacture of bone cells takes place in the laboratory of BioGroup Bonus in a sterile chamber in Haifa on a three-dimensional biodegradable scaffold that is a micro-environment conducive to growth in vivo of the human bone.

In the laboratory, fat cells are separated from cells capable of generating tissue and blood vessels. These are grown in a bioreactor that simulates the environment inside the human body and provides optimal conditions for bone generation.

BioGroup Bonus manufactures an injectable transplant made up of tiny live bone particles ready to be implanted in the missing part of the bone of the patient. After transplantation, the separated bone particles consolidate into autologous bone tissue (donor and recipient are the same individual, as opposed to heterologous) who repairs the injured bone in six weeks.

In August 2017, Bonus BioGroup first achieved an autologous bone graft in the forearm of a patient with severe bone loss, using the same technology. In a previous clinical trial, Bonus BioGroup achieved a revolutionary breakthrough with a single injection of human bone graft in participants with maxillofacial deficiencies, all genders, ages or medical contexts combined, with a success rate of 95%.

These results had never been achieved to date by any other medical treatment. Such a high rate of success on a small sample means that this success is not a coincidence, but that it will be replicable over a larger population.

In parallel, Bonus BioGroup has developed a second generation injectable bone graft that reduces manufacturing time, cost and mass production.

Global ambitions

Bonus BioGroup aims to be the first company in the world to manufacture and introduce on the global market of bone rehabilitation (estimated at $ 7.5 billion per year in 2017) a safe and fast solution to compensate for bone loss through a single autologous bone graft injection after laboratory culture from cells taken from the patient.

Currently, Bonus BioGroup is conducting two clinical trials for the second generation of its injectable bone graft defined in Phase I and II, with the objectives of evaluating the safety and effectiveness of its injectable bone graft.
1. In September 2016, a second clinical trial began to fill the bone void of the jaws, managed by Dr. Ephraim Tzur. Up to 20 patients, men and women aged 18 to 70, are expected to participate in the second clinical trial of jaw filling.
2. In August 2017, a clinical trial began to address critical bone defects in limbs, arms or legs; managed by Professor Nimrod Rozen, Head of Orthopedics at the Emek Center according to an agreement between Bonus BioGroup and the Clalit Health Fund.

The clinical trial must be performed for two indications: Severe bone loss from a failed long limb, due to failure of the natural body re-education process without medical intervention, or in case of failure the orthopedic procedure to repair the limb; comminuted fracture (presence of many fragments or splinters) extra-articular (outside the joint) of the bone of a long limb. TheClinical trial should include 30 to 40 participants, men and women, aged 18 to 75 years. In the first part of the trial, 10 participants will be recruited for both clinical indications; in the second part, 10 additional participants must be recruited for each of the two clinical indications and up to 30 additional participants for the two clinical indications together.

At the beginning of the first part of the clinical trial aimed at filling orthopedic bone defects, the safety of the use of the second generation of injectable bone graft is examined in three participants who are suitable for the first indication. This preliminary examination can be concluded in a few months.

Emek is one of the largest and most modern centers in Israel associated with the Clalit which provides medical services to more than 4.2 million people. Israel. The medical observation of each participant in the clinical trial must last six months from the date of implantation.

Bonus BioGroup has exclusive rights of use in six patent families, which include two patents and ten patent applications. Bonus BioGroup acts to register additional patents and patent applications, to achieve revolutionary breakthrough for additional indications.

Source: ©  Osteoporosis fractures: Bonus BioGroup (Israel) graft autologous bones grown in laboratory - Israel Science Info

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