Biotech company Matricelf has cleared a major regulatory hurdle, securing preliminary approval from Israel’s Ministry of Health to conduct compassionate use trials for engineered spinal cord tissue implants, according to announcements from Tel Aviv University and the Tel Aviv Sourasky Medical Center (Ichilov).
Clinical Manufacturing Agreement at Ichilov Hospital
To prepare for the landmark procedure, Matricelf signed a clinical manufacturing contract with the Tel Aviv Sourasky Medical Center (Ichilov). Production will take place inside cleanrooms at the Institute for Advanced Cellular Therapy (I-ACT), a Good Manufacturing Practice (GMP)-certified facility licensed by Israel’s Ministry of Health. According to project timelines, clinicians will collect blood samples from the first patient in approximately ten months, with the surgical procedure expected to follow a few months later.
“The cleanroom is a crucial component in our progress toward the first clinical trial in humans for people paralyzed as a result of trauma,” stated Prof. Tal Dvir, Head of the Sagol Center for Regenerative Biotechnology at Tel Aviv University (TAU) and Chief Scientific Officer at Matricelf, alongside Gil Hakim, CEO, and Dr. Alon Sinai, Founder and President of Matricelf. “Only production conducted in a cleanroom meets the requirements of regulators like the Ministry of Health, and it is therefore a fundamental prerequisite for submitting a human trial application.”
Prof. Eli Sprecher, CEO of the Tel Aviv Sourasky Medical Center and a member of TAU’s Gray Faculty of Medical & Health Sciences, emphasized the institution’s role in the partnership. “This partnership reflects Ichilov’s mission as a leading medical institution—not only in patient care but also at the forefront of medical innovation and research, creating solutions that will change the face of medicine in Israel and worldwide,” Sprecher stated.
Personalized Hydrogel and Stem Cell Technology
The underlying technology was developed in a laboratory at Tel Aviv University by Prof. Tal Dvir. The methodology bypasses the body’s inability to naturally regenerate torn spinal cord tissue. When trauma from car accidents, falls, or battlefield injuries tears the spinal cord, severed neurons fail to divide or renew themselves, leaving a permanent break in the transmission of electrical signals from the brain.
To bridge this gap, the treatment creates a fully customized three-dimensional implant. Clinicians draw blood cells from the patient and reprogram them via genetic engineering to function like embryonic stem cells. Concurrently, fat tissue harvested from the same patient provides collagen and sugars to formulate a personalized hydrogel. Researchers then combine the reprogrammed cells with the hydrogel to simulate the embryonic development of a spinal cord, yielding functional neuronal networks capable of transmitting electrical signals within roughly a month.
Advancing From Preclinical Animal Trials to Human Patients
Prior to receiving clearance for human trials, researchers tested the engineered implants on laboratory animals with chronic spinal cord injuries. According to Tel Aviv University project data, more than 80 percent of the test animals with long-term injuries regained full walking ability following the procedure. Buoyed by these preclinical results, the research team submitted findings to regulators, securing preliminary approval for an initial cohort of eight patients.
Developers plan to enroll patients whose paralysis is relatively recent, focusing on individuals within roughly one year of their injury. For the very first surgical procedure, the team selected an Israeli patient. “This is undoubtedly a matter of national pride,” Prof. Dvir noted regarding the decision to perform the world’s first surgery in Israel.