TEL AVIV, ISRAEL โ An Israeli-developed technology that uses a patient’s own cells to engineer personalized neural tissue is moving closer to its first transplantation in a person with paralysis, with preparations underway for a potential first treatment during the first half of 2027.
The technology originated in the laboratory of Prof. Tal Dvir at Tel Aviv University’s Sagol Center for Regenerative Biotechnology and is being developed commercially by Israeli biotechnology company Matricelf.
The company is preparing its investigational NewRal treatment for a first-in-human clinical trial involving people with traumatic spinal cord injuries.
The latest regulatory development came Sept. 3, when Matricelf announced it had received written feedback from the U.S. Food and Drug Administration’s Center for Biologics Evaluation and Research regarding its proposed clinical trial design.
According to Matricelf, the FDA feedback supported key elements of its proposed trial, including the intended patient population, a single-arm open-label design, primary safety assessments and exploratory measures of effectiveness.
The feedback is not FDA authorization to begin a human trial. Matricelf said it will use the agency’s guidance as it works toward a future Investigational New Drug application.
The development follows a series of steps in Israel that are bringing the technology closer to the clinic.
Matricelf has entered collaborations with Loewenstein Rehabilitation Medical Center of Clalit Health Services and Sheba Medical Center as it builds the clinical, manufacturing, and patient infrastructure required for a first human procedure.
If the remaining scientific, manufacturing, ethical, and regulatory requirements are met, Matricelf estimates treatment of the first selected patient could begin in the first half of 2027.
From An Israeli Laboratory Toward Human Treatment
The approach is designed to address one of medicine’s most difficult challenges: the limited ability of damaged spinal cord tissue to regenerate.
A serious spinal cord injury can sever or disrupt the neural pathways that transmit signals between the brain and the rest of the body. Depending on the location and severity of the injury, the result can include permanent loss of movement and sensation.
Dvir’s team has been working on a fundamentally different approach.
Rather than relying on a conventional synthetic implant, the technology seeks to manufacture personalized neural tissue using biological material derived from the individual patient.
Once an appropriate patient is identified and provides consent, blood can be collected and used to generate induced pluripotent stem cells, known as iPSCs. These are adult cells reprogrammed into a stem-cell-like state, allowing researchers to develop them into specialized cell types.
The cells become a component of an autologous neural implant. Autologous means the biological material originates from the same person who will receive it.
Matricelf’s objective is to create what Tel Aviv University has described as a biological “spare part” for damaged spinal cord tissue.
Using a patient’s own cells and tissues is intended to reduce the risk of immune rejection and improve the prospects for the engineered tissue to integrate with the patient’s body.
Whether those objectives can be achieved safely and effectively in humans remains to be determined through clinical testing.
Loewenstein Begins Patient Preparations
A major step came through Matricelf’s collaboration with Loewenstein Rehabilitation Medical Center, one of Israel’s leading rehabilitation hospitals.
Loewenstein is expected to identify and evaluate potential candidates for the treatment and assist patients through the clinical process.
In July, Matricelf announced it had received approval from Loewenstein’s Helsinki Committee and institutional leadership to collect blood samples from patients with complete spinal cord injuries classified as ASIA-A between the T2 and T12 levels.
Those samples are intended to generate the iPSCs required to manufacture personalized neural implants.
The authorization allows Matricelf to begin identifying and enrolling suitable patients as part of its preparations.
Crucially, however, the approval does not authorize implantation in people or initiation of the clinical trial itself. Those steps remain subject to further regulatory and ethical approvals, including authorization from Israel’s Ministry of Health.
Producing a personalized implant is expected to take several months. Starting patient identification and cell production in advance could allow manufacturing and regulatory preparations to proceed simultaneously.
Sheba Preparing For First-In-Human Program
Sheba Medical Center is also playing a central role in moving the Israeli technology toward clinical use.
Matricelf announced a strategic collaboration with Sheba in March to support its first-in-human spinal cord injury program.
Under that collaboration, the company began establishing Good Manufacturing Practice, or GMP, production of its autologous neural tissue implants at Sheba’s Advanced Biotherapy Center.
GMP standards govern how medical products intended for human use are manufactured and controlled.
In June, Matricelf announced that GMP manufacturing activities had begun at Sheba, allowing the company to validate its production process under conditions required for clinical development.
The first implantation procedure is expected to be performed at Sheba if the necessary approvals are obtained and the clinical program proceeds as planned.
Research Produced Promising Animal Results
The road toward a potential human trial began years earlier at Tel Aviv University.
In research announced in 2022, Dvir’s team reported engineering three-dimensional human spinal cord tissues and implanting them in laboratory models with long-term chronic paralysis.
The university reported that approximately 80 percent of the animals in the chronic injury model regained walking ability following implantation.
Those findings helped establish the scientific foundation for moving the technology toward human testing.
Animal results, however, cannot establish that a treatment will be safe or effective in people. The transition to a first-in-human trial is intended primarily to evaluate safety while beginning to explore whether the approach can produce meaningful clinical benefits.
Potentially Transformative, But Still Experimental
The significance of the Israeli program lies not in a proven cure for paralysis, which does not yet exist, but in its attempt to regenerate damaged neural tissue using a personalized biological implant.
Matricelf’s NewRal remains investigational. No engineered spinal cord transplant using this technology has yet demonstrated safety or effectiveness in a human patient.
The company’s recent FDA interaction also does not constitute approval to conduct the proposed U.S. trial.
Still, the accumulation of clinical partnerships, patient-selection preparations, GMP manufacturing and regulatory discussions marks a significant transition from laboratory research toward human clinical development.
If the remaining requirements are completed on schedule, Matricelf believes the first selected patient could receive the personalized neural implant during the first half of 2027.
For an innovation that began in an Israeli university laboratory, that procedure would represent its most important test yet: whether the promising regenerative results seen in preclinical research can begin to be translated safely into treatment for people living with paralysis.
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