First-ever spinal cord implant to treat paralysis without risk of rejection is successfully tested on mice; human trials are expected by end of 2024.

By Abigail Klein Leichman, ISRAEL21c 

Medical science has not yet found a way to restore walking ability in someone paralyzed from a traumatic spinal cord injury.

Within a few years, a first-of-its-kind 3D-printed spinal cord tissue implant, made from the patient’s own cells, could make that dream come true.

Using technology developed over the course of a decade in Prof. Tal Dvir’s regenerative biotechnology lab at Tel Aviv University, the implant enabled paralyzed lab mice to walk again.

A paper published today in Advanced Science provides the remarkable details.

“It is like science fiction,” says Dr. Asaf Toker, CEO of Matricelf, the company working to bring Dvir’s groundbreaking technology to market.

Two years ago, Dvir’s lab 3D-printed the world’s first miniature vascularized human heart.

Dvir and Alon Sinai cofounded Matricelf that year and it went public in 2021. On January 30, the company signed an exclusive global licensing agreement with Tel Aviv University technology transfer company Ramot to commercialize and utilize the patent for 3D-printing tissues and organs.

“With our technology, we can create any tissue we want,” Toker tells ISRAEL21c. “The first one is neural implants for people with a spinal cord injury causing paralysis.”

No rejection

Dvir explained that the technique begins with taking a small biopsy of belly fat tissue from the patient.

“This tissue, like all tissues in our body, consists of cells together with an extracellular matrix of substances like collagens and sugars,” he explained.

“After separating the cells from the extracellular matrix, we used genetic engineering to reprogram the cells, reverting them to a state that resembles embryonic stem cells capable of becoming any type of cell in the body.”

The extracellular matrix didn’t go to waste. It formed the basis of a personalized hydrogel that will not trigger an immune response or rejection after implantation – which is the main problem with donor implants.

“We then encapsulated the stem cells in the hydrogel and, in a process that mimics the embryonic development of the spinal cord, we turned the cells into 3D implants of neuronal networks containing motor neurons,” said Dvir.

The human spinal cord implants were then implanted in mice. Half had only recently been paralyzed (the acute model) and half had been paralyzed for the equivalent of a year in human terms (the chronic model).

Up and walking again

Following the implantation and a rapid rehabilitation process, 100 percent of the mice with acute paralysis and 80% of those with chronic paralysis regained their ability to walk.

“This is the first instance in the world in which implanted engineered human tissues have generated recovery in an animal model for long-term chronic paralysis – which is the most relevant model for paralysis treatments in humans,” Dvir said.

“Individuals injured at a very young age are destined to sit in a wheelchair for the rest of their lives, bearing all the social, financial, and health-related costs of paralysis” because there has never been an effective treatment, Dvir pointed out.

“Our goal is to produce personalized spinal cord implants for every paralyzed person, enabling regeneration of the damaged tissue with no risk of rejection.”

Following discussions with the U.S. Food and Drug Administration (FDA), Matricelf plans the first human clinical trial of the spinal cord implant at the end of 2024.

“Since we are proposing an advanced technology in regenerative medicine, and since at present there is no alternative for paralyzed patients, we have good reason to expect relatively rapid approval of our technology,” said Dvir.

In the meantime, additional efficacy and safety trials will be done on lab rats.

Printing tissues and organs

Toker explains what makes this technology unique.

“Tissue engineering requires two ingredients: cells and extracellular matrix as a scaffold for the cells to build the tissue,” he says.

“Many companies do tissue engineering using synthetic materials for scaffolds or using cells from a donor. But when you introduce foreign material to the body, the immune system attacks it, and the implant fails unless the patient takes drugs to suppress the immune system.”

The Matricelf technology developed by Dvir uses autologous (the patient’s own) cells and extracellular matrix. The immune system recognizes them and doesn’t attack them.

“The new licensing agreement with Ramot also enables us to 3D-print tissues and organs,” says Toker.

“An organ is built from a variety of tissues and cells. So our bioprinter has several bio-ink cartridges to print different tissues in the same printing, just like in four-color printing where the printer knows where to put each color.”

The bio-ink is enclosed inside another fluid to support the organ’s structure.

“When you print a hollow organ like a heart, if you don’t use this technology the tissue will collapse,” Toker explains. “To print organs with cavities inside them you need the technology to support it. That is our unique aspect.”

The spinal implant was developed by Dvir and lab members Lior Wertheim, Dr. Reuven Edri and Dr. Yona Goldshmit along with Prof. Irit Gat-Viks from the Shmunis School of Biomedicine and Cancer Research, Prof. Yaniv Assaf from the Sagol School of Neuroscience, and Dr. Angela Ruban from the Steyer School of Health Professions, all at Tel Aviv University.

Matricelf, based in Ness Ziona, employs 10 people – seven of whom are women, Toker tells ISRAEL21c. It is well-positioned to become a prominent player in the 3D bioprinting market, estimated to be worth about $650 million in 2019 and an expected $1.6 billion in 2024.

The post Israeli startup’s bioprinted implant may help paralyzed people walk again appeared first on World Israel News.

Head of Israel Biological Institute says 15 million doses of the single-shot vaccine produced, second phase of human trials about to begin.

By Paul Shindman, World Israel News

The head of the Israel Biological Institute told the Knesset’s Science and Technology Committee on Monday that the coronavirus vaccine being developed in Israel is expected to be ready during the summer of 2021, Channel 12 reported.

“We have the intention and ability to produce 15 million vaccines for the benefit of the citizens of the State of Israel and also for the benefit of neighbors close to us,” said Prof. Shmuel Shapira.

The Institute began the first human trials of the vaccine at the beginning of November using volunteers, and Shapira said the second phase of testing will begin “within a week to 10 days.”

“Our vaccine will need one shot and it has tremendous practical significance,” Shapira said, noting that the Israeli-made medicine is not a ‘logistical monster’ like the vaccine developed by the American company Pfizer that needs to be stored and distributed at extremely cold temperatures.

“We are talking about starting vaccinations during the summer. Our production capabilities are good and high. So far we have produced 3 million, we have the ability to finish phase 2 and 3 [testing] quickly and well,” Shapira said.

However, Shapria criticized the Health Ministry over what he called excessive regulation demands above and beyond what he considers normal.

“We have encountered delays in over-regulation and a very meticulous path that other companies in the world have not gone through,” Shapira stated, noting that he hoped to get approval for stage three testing by April, a point when, he said, the vaccine should already have been in the middle of the stage three test.

Shapira also leveled some criticism at the government of Israel, saying that “the wind at our back is not strong enough” because officials were giving more respect to “companies whose mother tongue is English, and more recently also companies whose mother tongue is Russian,” referring to Health Ministry efforts to obtain a new Russian vaccine.

“I think there is very good science here and leading scientists are behind us,” Shapira said. “I would like to receive the same support and sympathy that the giant companies that have a budget 30 times ours receive.”

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Scientists from the Hebrew University of Jerusalem have completed the mapping of the entire human genetic code, giving researchers the ability – for the first time – to understand the function of each of the 20,000-plus genes that make up the human genome.

The post WATCH: Breakthrough – Israeli scientists complete mapping of entire human genetic code appeared first on World Israel News.

Israel’s cCAM has received US FDA approval to commence trials of its CM-24 monoclonal antibody (mAb) for the treatment of various types of cancers. CM-24 targets CEACAM1, a novel immune checkpoint protein expressed on a variety of cancer cells.
https://finance.yahoo.com/news/ccam-biotherapeutics-receives-fda-approval-121500561.html

Israel & USA team up to fight cancer.

Israeli biotech Compugen has enlisted John Hopkins University to help assess Compugen’s cancer immunotherapy candidates. These new treatments aim to counter the ability of tumors to highjack “immune checkpoints”, thereby blocking the immune system’s ability to destroy the tumor.
https://www.israel21c.org/news/compugen-teams-with-johns-hopkins-university-on-immune-checkpoints/

Effective for detecting lingering cancer cells.

New York City’s NYU Langone Medical Center has praised MarginProbe from Israel’s Dune Medical, used by surgeons to identify and help them remove cancer cells on the margins of removed tumors. MarginProbe avoids the need for follow-up surgery.
https://communications.med.nyu.edu/media-relations/news/nyu-langone-medical-center-utilizing-new-technology-detect-lingering-cancer-cel

90% response to cancer vaccine.

Julian Levy, CFO of Israel’s Vaxil Biotherapeutics speaks to NoCamels about Vaxil’s cancer vaccine, ImMucin, that boosts the immune system and prevents cancer returning. ImMucin triggers a response in about 90 percent of all types of cancer.
https://nocamels.com/2015/01/new-vaccine-for-cancer/

US approve 360-degree colonoscope.

Israel’s GI View has just received US FDA approval for its Aer-O-Scope colonoscope, for advanced detection of polyps that frequently develop into colon cancer. GI View is expected to start selling the product in the U.S. in early 2016.
https://www.giview.com/gi-view/news.html

Spine surgery system wins two awards.

Israel’s NLT-Spine has won a 2014 Spine Technology Award from US Magazine Orthopedics This Week, for its ARC Pedicle Screw System. The company also was included (for the second year running) in the list of Red Herring Global 100 winners.

https://www.nlt-spine.com/int/news-2/

Maya Fishman, Age 16 .

Med school at 16.

If Israelis are exceptional people, then Maya Fishman is amazing. Only 16-years old, she has already started med school at the Hebrew University in Jerusalem. She is on course to become the youngest doctor in the history of the State of Israel.
https://www.ynetnews.com/articles/0,7340,L-4606194,00.html

What lurks in your lungs?

Professor Elizabeth Fireman of Tel Aviv’s Sourasky Medical Center has developed a highly accurate bio-monitoring technique to detect dangerous particles inhaled by firefighters, factory workers, dental technicians and kids with asthma.
https://www.israel21c.org/headlines/revolutionary-diagnostic-technique-identifies-what-lurks-in-your-lungs/

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While the international media insists on placing a negative focus on Israel, it’s important to know about the positive contributions Israel makes.  Here’s some of the latest news from Israel in the area of medicine.

Preventing Deadly Infections

An anti-inflammatory drug, alpha1-antitrypsin (AAT), could be effective in preventing deadly infections in patients with compromised immune systems, researchers at Ben Gurion University of the Negev (BGU) announced last week.

As reported in the Journal of Infectious Diseases, the study, led by Dr. Eli C. Lewis and his team of BGU researchers, examined the effectiveness of AAT as treatment against the growth and spread of bacteria.

Bacterial infections in patients with compromised immune systems can lead to sepsis, multiple organ dysfunction and death, even with the treatment of antibiotics. This is especially problematic when such individuals experience prolonged hospitalization, where they are exposed to large amounts of bacteria.

The unexpected discovery occurred when mice were treated with AAT in an effort to determine whether the drug would strengthen infections. To the researchers’ surprise, the treated mice combated lethal infections better than did untreated mice, and bacteria directly introduced into their systems were almost completely eradicated by the AAT therapy within 24 hours.

This discovery is especially promising as the current rate of bacterial resistance in antibiotics and the rate of development of new antibiotics are insufficient. Dr. Lewis, world-renowned expert on autoimmune disease and head of the Clinical Islet Laboratory at BGU, says the implications are immense.

The BGU team is working on developing this information into safe, preemptive and readily accessible treatment for humans. As the research develops, their work will be published in future studies.

Nano-Particles to Attack Cancer

Tel Aviv University Professors Rimona Margalit and Dan Peer have developed a breakthrough in the treatment of cancer that has caught the attention of the international medical community.

The breakthrough is a drug delivery platform that uses “GAGomers,” a new class of nanoparticles, coated with glycosaminoglycan or GAGs, a polysugar that specifically targets tumors and blood cancers. The technology utilizes a biomarker that is expressed on malignant tissue.

In 2010, Pontifax, a leading Israeli venture capital firm, established Quiet Therapeutics, a bio-pharmaceutical company, in order to make Margalit’s and Peer’s platform accessible and marketable to oncology patients and their doctors.

In a nutshell, this new technology allows for much more efficient treatment by targeting the cancer cells with fewer drugs and, therefore, minimizing side effects.

Early Detection

Researchers at Hadassah Medical Center in Jerusalem have made a breakthrough discovery that would allow early detection, and possibly prevention, of colon and uterine cancers.

According to the study, a specific genetic mutation has been found that increases the risk of developing these types of cancers. This would help to identify at-risk patients, thus increasing successful treatment and reducing costs.

The research group was led by Dr. Yael Goldberg of the Sharett Institute of Oncology at Hadassah and included scientists from Hadassah, Rabin Medical Center in Petach Tikva and Sourasky Medical Center in Tel Aviv.

“The study is of immense importance in the prevention and early treatment of cancer. Identifying the genetic mutation allows us to find subsets of healthy people who carry that mutation and put them on an early prevention and observation program. Early detection of cancer is one of the most important tools in healing the deadly disease,” Prof. Tamar Peretz, senior oncologist and acting director-general of Hadassah, stated.

By: Atara Beck, World Israel News

The post Once Again, Israeli Discoveries Promise Medical Breakthrough appeared first on World Israel News.