{"id":33711,"date":"2025-02-17T17:32:40","date_gmt":"2025-02-17T17:32:40","guid":{"rendered":"https:\/\/cells4life.com\/?p=33711"},"modified":"2025-09-29T16:06:22","modified_gmt":"2025-09-29T16:06:22","slug":"leukemia-treatment-cord-blood-clinical-trials","status":"publish","type":"post","link":"https:\/\/cells4life.com\/us\/2025\/02\/leukemia-treatment-cord-blood-clinical-trials\/","title":{"rendered":"Leukemia Treatment Derived From Cord Blood Gains FDA Approval for Clinical Trials"},"content":{"rendered":"[et_pb_section fb_built=”1″ _builder_version=”4.16″ global_colors_info=”{}”][et_pb_row _builder_version=”4.16″ background_size=”initial” background_position=”top_left” background_repeat=”repeat” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.16″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_text _builder_version=”4.27.4″ background_size=”initial” background_position=”top_left” background_repeat=”repeat” global_colors_info=”{}”]\n

A CAR-T cell therapy for acute lymphoblastic leukemia[1]<\/a> has recently been approved by the FDA for use in clinical trials in the United States. The therapy is based on cells derived from allogeneic (donor) umbilical cord blood; it is the very first such treatment to gain FDA approval.[2]<\/a><\/p>\n

What is acute lymphoblastic leukemia?\u00a0<\/span><\/h3>\n

Acute lymphoblastic leukemia, or ALL, is a type of blood cancer that starts in the bone marrow. It affects white blood cells (lymphocytes).<\/p>\n

In ALL, the bone marrow makes too many of the cells from which lymphocytes derive (lymphoblasts). These lymphoblasts grow and divide quickly; however, they are not fully developed and cannot turn into healthy lymphocytes.<\/p>\n

As a result, lymphoblasts build up in the bone marrow and stop all types of healthy blood cells from developing. They may also spread into other parts of the body, including lymph nodes, the liver and spleen, and the brain and spinal cord.[3]<\/a><\/p>\n

The lack of healthy white blood cells means ALL patients are at a higher risk of infection. ALL can also cause anemia through the lack of red blood cells, as well as bleeding problems due to lower platelet numbers.[4]<\/a><\/p>\n

Leukemia is the most common type of cancer which affects children; of all types of leukemia, ALL is the most commonly diagnosed in children.[4]<\/a> It can also affect adults, although this is less common.[3]<\/a><\/p>\n

What is CAR-T cell therapy?<\/span><\/h3>\n

CAR-T therapy is a type of treatment which uses T cells to fight cancerous cells. The T cells are genetically modified using a viral vector to add a specific protein on their surface, called a chimeric antigen receptor (CAR). This addition makes them able to recognize cancerous cells and destroy them.[5]<\/a><\/p>\n

In standard CAR-T therapy, the T cells used are the patient\u2019s own, extracted from the blood through a process called apheresis. After extraction, they are taken to a specialized lab to be modified. However, this process is very time-consuming, typically requiring three to five weeks for manufacturing and quality checking. This can be a problem in the case of ALL, as the disease is fast-progressing and could worsen before the CAR-T cells are ready to be reinfused.[6]<\/a><\/p>\n

What makes this new therapy different?<\/span><\/h3>\n

The new therapy uses T cells derived from allogeneic (someone else\u2019s) cord blood as a starting point instead. These cells are in a more naive state, meaning they have a higher ability for self-renewal and lower immunogenicity. This means a lower chance to provoke an immune response when used in treatment. As a result, they can be developed into an \u2018off-the-shelf\u2019 CAR-T therapy that is ready when needed and does not require a long wait.[2]<\/a> Following positive results from investigator-initiated trials,[1]<\/a> the FDA has now approved the therapy for clinical trials in the United States.[2]<\/a> Furthermore, researchers in China are also testing the therapy in a clinical trial for the treatment of lupus.[7]<\/a>[8]<\/a><\/p>\n

A similar therapy, also based on T cells derived from donor cord blood, is being developed at the Fondazione Tettamanti research center in Monza, Italy. Using a special DNA sequence called a transposon, scientists turn the T cells into CAR-enabled cytokine-induced killer cells (CARCIK), making them able to destroy cancer cells. An initial set of clinical trials aimed at determining the feasibility and safety of this treatment showed positive results. Researchers are now continuing to test the therapy in clinical trials for ALL as well as non-Hodgkin lymphoma, and in vitro and animal models for acute myeloid leukemia.[9]<\/a><\/p>\n

The benefits of using cord blood for treatments<\/span><\/h3>\n

Being able to derive T cells for CAR treatment from cord blood could pave the way towards more targeted therapies in the future, says Sarah Tettamanti, a researcher at Fondazione Tettamanti. These therapies could be developed from banked cord blood compatible with each specific patient.[9]<\/a><\/p>\n

For treatments such as these, it could be essential to have ready access to a compatible donor match. Public cord blood banks are available in the UK, US and worldwide. However, because they rely on donated cords, there is no guarantee that a match will be found when needed.<\/p>\n

Conversely, if you store your baby\u2019s cord blood privately at birth, they will always have access to their own perfect match if they ever need it. There is also a 25% chance for the cord blood to be a perfect match for a sibling and 50% chance of a partial match. It is guaranteed to always be a partial match for parents.<\/p>\n

It could also prove to be a match for a more distant relative \u2013 which thanks to cord blood cells\u2019 naive state and lower immunogenicity, could still be enough for treatment.<\/p>\n

To learn more about the potential uses of cord blood in treatments and how you could preserve this precious resource for your baby and family, fill in the form below and request our free info kit.<\/p>\n

References<\/h3>\n

[1] LemanBio (2023). Leman Biotech and Ucello Therapeutics enter into Comprehensive Strategic Collaboration to Advance Universal CAR-T Development<\/i>. https:\/\/www.lemanbio.com\/en\/news\/197.html<\/span><\/a><\/p>\n

[2] BusinessWire. (2025).\u00a0VectorBuilder Powers FDA IND Approval of World\u2019s First Umbilical Cord Blood-Derived Allogeneic CAR-T Product<\/i>. https:\/\/www.businesswire.com\/news\/home\/20250129313138\/en\/VectorBuilder-Powers-FDA-IND-Approval-of-World%E2%80%99s-First-Umbilical-Cord-Blood-Derived-Allogeneic-CAR-T-Product<\/span><\/a><\/p>\n

[3] Cancer Research UK (2021).\u00a0What Is Acute Lymphoblastic Leukaemia (ALL)?<\/i>\u00a0https:\/\/www.cancerresearchuk.org\/about-cancer\/acute-lymphoblastic-leukaemia-all\/about<\/span><\/a><\/p>\n

[4] Cancer Research UK (2021).\u00a0About childhood acute lymphoblastic leukaemia (ALL).<\/i>\u00a0https:\/\/www.cancerresearchuk.org\/about-cancer\/childrens-cancer\/acute-lymphoblastic-leukaemia\/about<\/span><\/a><\/p>\n

[5] Cancer Research UK (2021).\u00a0CAR T-cell therapy.<\/i>\u00a0https:\/\/www.cancerresearchuk.org\/about-cancer\/treatment\/immunotherapy\/types\/CAR-T-cell-therapy<\/span><\/a><\/p>\n

[6] Leukemia & Lymphoma Society. Chimeric Antigen Receptor (CAR) T-Cell Therapy<\/i>. https:\/\/www.lls.org\/treatment\/types-treatment\/immunotherapy\/chimeric-antigen-receptor-car-t-cell-therapy<\/span><\/a><\/p>\n

[7] https:\/\/mp.weixin.qq.com\/s\/t7tQTUwpl5vmr78cSRXGhQ<\/span><\/a><\/p>\n

[8] https:\/\/mp.weixin.qq.com\/s\/rVx9bVuU3-2pKio_LbO7ZQ<\/span><\/a><\/p>\n

[9] Cerati, F. (2025).\u00a0Dal cordone ombelicale le cellule modificate per trattare la leucemia<\/i>. Il Sole 24 Ore. https:\/\/www.ilsole24ore.com\/art\/dal-cordone-ombelicale-cellule-modificate-trattare-leucemia-AGD2eidC<\/span><\/a><\/p>\n[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ module_class=”down-arrow” _builder_version=”4.27.4″ background_color=”#bd144f” custom_padding=”0px|||” locked=”off” global_colors_info=”{}”][et_pb_row _builder_version=”4.16″ background_size=”initial” background_position=”top_left” background_repeat=”repeat” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.16″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_text admin_label=”RWP” module_id=”request-welcome-pack” _builder_version=”4.27.4″ background_size=”initial” background_position=”top_left” background_repeat=”repeat” background_layout=”dark” use_border_color=”off” global_colors_info=”{}”]\n

FIND OUT MORE, REQUEST YOUR FREE INFO KIT TODAY<\/h3>\n

All you need to know to make an informed decision.<\/p>\n

Provide your contact details to request:<\/p>\n

– Complete Info Kit and your Guide to Cord Blood Banking
– Information via email
– Contact from our specialist advisors<\/p>\n

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