image: Matricelf and Tel Aviv Sourasky Medical Center (Ichilov) teams at the signing of the cleanroom manufacturing agreement.
Credit: Tel Aviv Sourasky Medical Center (Ichilov).
Following the agreement with Tel Aviv Sourasky Medical Center (Ichilov), Matricelf is beginning preparations for setting up a production line for the implants, in accordance with the regulatory requirements of Israel's Ministry of Health. It is expected that in about ten months, blood and fat samples will be collected from the first patient, in preparation for implantation. Matricelf’s innovation is based on a revolutionary tissue engineering technology developed at Tel Aviv University by Prof. Tal Dvir.
Matricelf biotech company announced significant progress on the path toward the world’s first-of-its-kind treatment for paralysis resulting from spinal cord injuries. The groundbreaking procedure, originating in a lab at TAU, aims to enable paraplegics to walk again. The treatment involves implanting functional, engineered, and patient-specific nerve tissues — allowing patients to rise from their wheelchairs and walk again, restoring their independence.
Recently, Matricelf received preliminary approval from Israel's Ministry of Health to begin compassionate use trials in eight patients. This scientific breakthrough is based on the revolutionary organ engineering technology developed by Prof. Tal Dvir, Head of the Sagol Center for Regenerative Biotechnology at TAU and Chief Scientific Officer at Matricelf.
A few days ago, Matricelf and the Tel Aviv Sourasky Medical Center (Ichilov) signed a contract for clinical manufacturing in cleanrooms at the Institute for Advanced Cellular Therapy (I-ACT). This means that the company will soon start manufacturing the implants in compliance with the regulatory standards of Israel's Ministry of Health and other authorities. According to estimates, within about ten months, blood samples will be taken from the first patient, leading to a procedure expected to take place a few months later.
The Institute for Advanced Cellular Therapy at Ichilov is a GMP-certified (good manufacturing practice) facility, licensed by Israel's Ministry of Health to produce advanced cellular therapies. Production takes place in cleanrooms, a controlled environment enabling aseptic manufacturing of sterile implants, to ensure both product quality and patient safety.
Prof. Tal Dvir, Gil Hakim, CEO and Dr. Alon Sinai, Founder and President of Matricelf, explained: “The cleanroom is a crucial component in our progress toward the first clinical trial in humans for people paralyzed as a result of trauma. 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. The facility at Ichilov is a manufacturing center that operates under strict international standards consistent with our own requirements. The combination of an advanced manufacturing infrastructure and groundbreaking technology allows us to offer an innovative, safe, and potentially life-changing treatment for paraplegics worldwide."
Prof. Eli Sprecher, CEO of the Tel Aviv Sourasky Medical Center (Ichilov) and member of TAU’s Gray Faculty of Medical & Health Sciences, added: “We are proud to take part in this groundbreaking collaboration with Matricelf, which combines advanced Israeli science, a world-class clinical manufacturing infrastructure, and real hope for millions of people around the world. 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."