Spinal cord implant

Israel is preparing to perform the world’s first-ever human spinal cord implant using a patient’s own cells, a medical breakthrough that could allow paralyzed patients to stand and walk again, Tel Aviv University announced on Wednesday.

The surgery, expected in the coming months, will take place in Israel and marks a historic milestone in regenerative medicine.

According to the World Health Organization, over 15 million people worldwide are living with spinal cord injuries, with the majority resulting from traumatic causes such as falls, road traffic accidents, and violence.

Currently, spinal cord injuries cannot be fully cured, so treatment focuses on stabilizing the patient, preventing further damage, and maximizing function.

Emergency care often involves immobilizing the spine, reducing inflammation, and sometimes performing surgery to repair fractures or relieve pressure.

Rehabilitation includes physical and occupational therapy, as well as assistive devices like wheelchairs and braces.

https://worldisraelnews.com/worlds-first-human-spinal-cord-implant-to-take-place-in-israel/

Israeli medical breakthrough aims to help disabled walk again

Researchers at Tel Aviv University say they have developed an artificial human spinal cord that was implanted in mice, resulting in over 80% of the tested species being able to move again, having been chronically paralyzed

A new Israeli medical breakthrough is aiming to give disabled individuals the ability to walk, using technology that may signal a dramatic change in the field of treatment of paralyzed people.

A team of researchers at Tel Aviv University, led by Prof. Tal Dvir, managed to develop a human spinal cord and implant it in mice suffering from chronic paralysis.

The research was published Monday in the prestigious Advanced Science Journal released by the Wiley-VCH.

The new method is based on performing a biopsy of human fat tissue from the patient's abdomen. Then, in a process that mimics the embryonic development of the spinal cord, the researchers transformed the cells into human spinal implants.

According to estimates, in order to treat paralyzed people, tens or hundreds of implants will be required for each patient, and the development of each implant would take some five years.

Prof. Dvir and his team members divided the mice suffering from paralysis into two groups: mice with short-term acute paralysis, and mice with long chronic paralysis. After the procedure, all the mice who suffered acute paralysis and 80% of the mice who suffered from chronic paralysis could move and walk again.

The experiment has been conducted so far on mice only, but the university estimates that within two to three years it will be possible to begin clinical trials with human subjects, with the aim of finding out whether the implant can help treat spinal cord injuries in general, and paralysis in particular.

Prof. Dvir explained that the implants are meant to help paralyzed people who either can't walk or move their arms and legs. "The implants we used on mice are human implants and they were made out of human cells, but the number of implants needed for the mice is lower than the one we need to fill the same damaged area in humans. There are still many challenges, but we are optimistic," he said.

Prof. Dvir said his team has been working to develop the technology for some five years.

"Based on this technology, we founded Matricelf company two years ago, and our goal is to bring this technology to the clinics. We produce implants for humans and we are already in discussions with the FDA about approvals. Our ambition is that in two to three and a half years we will be ready for clinical trials.

"The implants demonstrated how paralyzed animals managed to walk again just a few weeks later, and our ambition is that paralyzed people would be able to achieve the same result, and just get out of the wheelchair and start walking, that's our goal and that's where we are heading," Prof. Dvir added.

https://www.ynetnews.com/health_science/article/hkbzfpack

Tel Aviv University researchers have grown human spinal cord stem cells, aiming to help paralyzed patients walk again; after successful animal trials, Health Ministry approves moving forward with human testing

Imagine a reality where a person who lost the ability to walk due to war, an accident or an injury undergoes surgery and rises to their feet again. A team of Israeli scientists is bringing that dream closer to reality.

In 2022, researchers at Tel Aviv University successfully engineered a human spinal cord in a laboratory for the first time. Since then, progress has been rapid, and animal experiments have shown unprecedented success. Now, Ynet has learned, the real test is approaching: the first surgery in a human patient, which could enable a paralyzed person to walk again within a year.

The development is led by Prof. Tal Dvir, head of the Sagol Center for Regenerative Biotechnology and the Nanotechnology Center at Tel Aviv University, as well as chief scientist of the biotech company Matricelf. The company was founded in 2019 based on the groundbreaking organ-engineering technology developed by Dvir and his team at the university, under a licensing agreement with Ramot, Tel Aviv University’s technology transfer company.

“The spinal cord is made up of nerve cells that transmit electrical signals from the brain to all parts of the body,” Dvir explained. “The decision is made in the brain, the signal passes down the spinal cord, and neurons activate the muscles. When the cord is torn by trauma — a car accident, a fall or a battlefield injury — the chain is cut. Imagine an electric cable: when two ends don’t touch, the signal doesn’t pass. The cable won’t conduct electricity, and the person cannot pass signals beyond the injury.”

That, he said, is the major difficulty. Spinal cord injury is one of the few traumas in the body with no natural ability to regenerate. “Neurons don’t divide or renew themselves. They’re not like skin cells, which can repair wounds. They’re like heart cells: once damaged, the body cannot restore them,” Dvir said. “The damage stabilizes at some point, but by then the paralysis is already severe. Over time scar tissue forms, blocking signals, leaving the patient paralyzed below the injury — in the arms and legs if it’s in the neck, or just the legs if in the lower back.”

Dvir first began developing the technology years ago for heart tissue and other organs. Only in 2018 did his team apply it to the spinal cord. The concept is simple to understand but complex to execute.

“The goal is to build a small piece of spinal cord that behaves like the real thing. We can remove the scar tissue, implant the engineered tissue in its place and eventually fuse the new piece with the existing cord above and below the injury. Think of it as inserting a conductor between two cut cable ends, restoring communication,” he said.

The challenge is rejection by the body's immune system. “When tissue comes from another source, the body may attack it. Even if the implant is good, the immune system creates a fibrotic layer around it that blocks the electrical signal,” he explained. “That happens with many implants — breast implants, pacemakers. But here, where the tissue must conduct electricity, insulation ruins the function.”

To overcome this, the team developed a personalized solution. “We take blood cells from the patient. They’re not neurons, but using a Nobel Prize–winning technology from 2012, we reprogram them into stem cells with the ability to become any cell in the body,” Dvir said.

Next comes tissue construction. “Cells alone aren’t enough — if we inject neurons, they’ll die. They need to be organized into tissue,” he said. The researchers harvest fat tissue from the patient, extract collagens and sugars, and use them to create a gel. “This gel is also personalized, just like the cells. We place the reprogrammed stem cells in it and mimic embryonic spinal cord development.”

The result is a full 3D implant. “After a month, we have a three-dimensional tissue full of motor neurons transmitting electrical signals,” he said. “We then implant it at the site of the injury.”

From animals to humans

To test the method, the team began with lab animals. The results were dramatic. “We treated animals with chronic injuries, more than a year old. Over 80% regained the ability to walk perfectly,” Dvir said.

Now comes the human trial. “We submitted our results to Israel’s Health Ministry. Six months ago, we received initial approval for compassionate-use trials in eight patients. Of course, the first patient will be Israeli,” Dvir said. “The technology was developed here, and I trust Israeli surgeons to perform it best. We already have approval to begin drawing blood as soon as the first patient is chosen and cleared.”

The treatment is initially limited to relatively recent injuries, less than a year old. “We won’t start with the most severe cases,” Dvir said. “But once we prove it works, the possibilities are open. We’ll then define criteria like age and injury location, but ultimately, I believe this will help all patients with paralysis.”

Alongside Dvir, key figures driving the project include Matricelf CEO Gil Hakim; Co-founder, Deputy CEO and President Dr. Alon Sinai and Vice President R&D Dr. Tamar Harel Adar with her team. “They got us to approvals so quickly — it’s amazing,” Dvir said.

https://www.ynetnews.com/health_science/article/skk700dgklx

Wertheim L, Edri R, Goldshmit Y, Kagan T, Noor N, Ruban A, Shapira A, Gat-Viks I, Assaf Y, Dvir T. Regenerating the Injured Spinal Cord at the Chronic Phase by Engineered iPSCs-Derived 3D Neuronal Networks. Adv Sci (Weinh). 2022 Apr;9(11):e2105694. doi: 10.1002/advs.202105694. Epub 2022 Feb 7. PMID: 35128819; PMCID: PMC9008789.

Abstract

Cell therapy using induced pluripotent stem cell-derived neurons is considered a promising approach to regenerate the injured spinal cord (SC). However, the scar formed at the chronic phase is not a permissive microenvironment for cell or biomaterial engraftment or for tissue assembly. Engineering of a functional human neuronal network is now reported by mimicking the embryonic development of the SC in a 3D dynamic biomaterial-based microenvironment. Throughout the in vitro cultivation stage, the system's components have a synergistic effect, providing appropriate cues for SC neurogenesis. While the initial biomaterial supported efficient cell differentiation in 3D, the cells remodeled it to provide an inductive microenvironment for the assembly of functional SC implants. The engineered tissues are characterized for morphology and function, and their therapeutic potential is investigated, revealing improved structural and functional outcomes after acute and chronic SC injuries. Such technology is envisioned to be translated to the clinic to rewire human injured SC.