Ever since German researcher Ernst Haeckel coined the term “stem cell” in the mid-19th century, biology research has advanced exponentially in its efforts to use cells as therapeutic instruments. As of today, cell therapy is defined as the transfer of cells from an individual with the aim of replacing or repairing the function of injured cells or tissues in another. Among the cytotherapies with the greatest potential is immunotherapy, an area of therapy now being intensely researched, in which T-cells can be used to modulate the response of the immune system to different types of cancer.
The Cellular Production Support Unit of the Andalusian Molecular Biology and Regenerative Medicine Centre (CABIMER) offers a technological service focused on the production of human cells considered medications. This technological core, which forms part of Biocores, “meets the legal conditions required for the manufacture of cellular medicaments,” states its Technical Director, Dr. Karim Hmadcha. The management body of the Unit is the “Health and Progress Foundation”, an organization of the Andalusian Autonomous Government’s Ministry of Health.
This unit “is devoted to obtaining and expanding autologous adult mesenchymal stem cells derived from expanded adipose tissue for their use in humans, both in clinical trials as well as compassionate use,” says Dr. Hmadcha in remarks to Biocores. The unit was established in 2006. Three years later, the Spanish Agency of Medicinal Products and Medical Devices (AEMPS) approved the Cellular Production Unit for Research Medications for human use, which became Andalusia’s first authorized cell production laboratory. In 2012 and 2015, the organization was newly accredited to carry out isolation and expansion of mesenchymal stem cells.
From the time of its implementation and approval by the AEMPS, as Karim Hmadcha tells Biocores, the Unit has taken part in the manufacturing of human autologous cell-based medicinal products to treat patients recruited in four different clinical trials. To wit, the UAPC-CABIMER has cooperated as a production unit contracted for studies designed to assess the safety and efficacy of cell therapy application to treat chronic critical lower limb ischemia syndrome for diabetic and non-diabetic patients; and for secondary progressive multiple sclerosis in patients that did not respond as hoped to registered treatments.
Image provided by UAPC-CABIMER
CABIMER’s Cellular Production Support Unit has manufactured 83 clinical batches and ten compassionate use batches, “which is equivalent to over 8.8 billion cells created to improve the health of the population, and integrate advanced therapies into Andalusia as an element of innovation in health care,” states Dr. Hmadcha. Since last year, the UAPC-CABIMER has also been taking part in a research project financed by the Carlos III Institute of Health, in which the unit is “preparing a cellular medicament that is based on manufacturing an encapsulated and insulin-producing cells from human pluripotent cells.”
The activity of the unit, which is part of the Cellular Production Platform of the Spanish Cell Therapy Network (Red TerCel of the Carlos III Institute of Health), has given rise to numerous scientific publications and patents. The unit “has qualified staff members who cover quality assurance and carry out all necessary quality controls related to manufacturing of the cellular product, in addition to subjecting the facilities, materials, reagents, equipment and staff members taking part in the process to strict, ongoing inspections (standardized protocols),” concludes its leader.