Allogeneic cell therapy is a type of cell therapy in which a patient receives cells from a donor. Bone marrow transplants are a type of allogeneic cell therapy. Allogeneic therapy products may also be called universal cell therapy products or off-the-shelf cell therapy products. In contrast, autologous cell therapy uses cells that are derived from a patient’s own cells.
Allogeneic cell therapies carry the risk of immune rejection but also have potential advantages over autologous cell therapy. Since cells do not need to be extracted from the patient and prepared, allogeneic cell therapy products are more immediately available to the patient. Allogeneic cell therapy products could potentially allow less variability and more standardization and allow for an industrialized process to decrease the cost of production.
- Stratagraft (allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen – dsat), manufactured by Stratatech Corporation, is used for the treatment of deep, partial-thickness burns.
Congenital athymia is a disease characterized by the absence of a functioning thymus, which results in profound immunodeficiency, increased susceptibility to infections, and an increased risk of graft-versus-host disease (GVHD). Most infants with congenital athymia have CHARGE syndrome or have a deletion of genetic material at chromosome 22q11.2. Infants have a higher risk of congenital athymia if they were exposed to retinoic acid during pregnancy or were born to diabetic mothers.
- Rethymic (allogeneic processed thymus tissue-agdc), manufactured by Enzyvant Therapeutics GmbH, is indicated for immune reconstitution in pediatric patients with congenital athymia.
The following products are hematopoietic progenitor cells (HPC) derived from umbilical cord blood used to treat disorders affecting the hematopoietic system that are inherited, acquired, or resulting from myeloablative treatment.
- Allocord, manufactured by SSM Cardinal Glennon Children’s Medical Center
- Clevecord, manufactured by Cleveland Cord Blood Center
- Ducord, manufactured by Duke University School of Medicine
- Hemacord, manufactured by New York Blood Center, Inc.
- HPC/Cord blood, manufactured by Clinimmune Labs, University of Colorado Cord Blood Bank
- HPC/Cord blood, manufactured by MD Anderson Cord Blood Bank
- HPC/Cord blood, manufactured by LifeSouth Community Blood Centers, Inc.
- HPC/Cord blood, manufactured by Bloodworks
- Omisirge, manufactured by Gamida Cell Ltd., is a nicotinamide-modified allogeneic HPC therapy to treat hematologic malignancies as part of myeloablative treatment.
- GINTUIT (Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen), manufactured by Organogenesis Incorporated, is an allogeneic cellularized scaffold product indicated for topical use in a surgically created vascular wound bed in the treatment of mucogingival conditions.
- Lantidra is an allogeneic pancreatic islet cellular therapy manufactured by CellTrans Inc.
- CARTISTEM, an allogeneic umbilical cord blood–derived MSC product used in treating patients with degenerative arthritis, approved in Republic of Korea
- Ebvallo (Atara Biotherapeutics), an allogeneic T-cell immunotherapy that has been approved for EU patients with relapsed or refractory Epstein‑Barr Virus positive, post‑transplant lymphoproliferative disease
- Stempeucel® (developed by Stempeutics Research), allogeneic mesenchymal stem cells (MSC) derived therapy used to treat critical limb ischemia, approved by DCGI (India FDA)
Cancer immunotherapies are treatments that activate or strengthen immune response to cancer cells or prevent tumor cells from suppressing the body’s immune response. T cells and natural killer (NK) cells are among the immune cells with antitumor activity. Chimeric antigen receptor-engineered (CAR) T cell therapy treats a patient with T cells that are modified to have enhanced targeting toward cancer cells. CAR NK cells are NK cells with enhanced cancer targeting.
As of 2021, most CAR T therapies in clinical trials were autologous CAR T cell therapies. All FDA-approved CAR T therapies (Abecma, Breyanzi, Carvykti, Kymriah, Yescarta) are autologous cell therapies. Allogeneic CAR T therapies are in preclinical and clinical development.
Natural killer (NK) cells are a type of lymphocyte (white blood cell) that controls viral infections and recognizes and kills malignant cells. NK cells also produce cytokines and chemokines, secreted signaling molecules that regulate other cells in inflammatory and immune responses. The three main sources of allogeneic NK cells are 1) donor peripheral blood, 2) cord blood or differentiation from cord blood hematopoietic stem and progenitor cells (HSPCs), or 3) induced pluripotent stem cells (iPSCs).
Allogeneic NK cells do not cause graft-versus-host disease (GVHD), giving them an advantage over allogeneic CAR T-cell therapies. Other advantages of NK cell therapies over CAR T-cell therapies include reduced cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome toxicity.
Mesenchymal stromal cells (MSCs) are a heterogeneous population of cells that, when expanded in vitro, include stem, progenitor, and differentiated cells. MSCs have regenerative potential and anti-inflammatory properties. However, MSC treatments in clinical trials have produced mixed results. No cell therapies using MSCs have been FDA-approved.
- Allogeneic limbal transplantation for the treatment of limbal stem cell deficiency (LSCD), a disease of the eye
- Allogene Therapeutics developed ALLO-715 and ALLO-647, two allogeneic CAR T cell therapies in cancer clinical trials as of 2023.ALLO-715 is an allogeneic, anti-BCMA CAR T cell therapy developed to treat multiple myeloma. ALLO-715, manufactured by Allogene, is prepared from peripheral blood mononuclear cells from healthy donors. ALLO-715 targets BCMA, a protein expressed on the surface of mature B lymphocyte and plasma cells that plays a role in myeloma cell survival and proliferation. BCMA is a target for multiple myeloma because it is overexpressed and activated in multiple myeloma.
- Appia Bio
- Atara Biotherapeutics
- Artiva Biotherapeutics
- Bellicum Pharmaceuticals
- Bristol Myers Squibb
- CARsgen Therapeutics
- Cell Design Labs
- Cellectis
- Cell Medica
- Celularity
- Celyad Oncology
- Century Therapeutics
- Fate Therapeutics
- Fortress Biotech
- Kite Pharma
- Mustang Bio
- Pfizer
- Precision BioSciences
- Poseida Therapeutics
- Sorrento Therapeutics
- Ziopharm Oncology
- Cellenkosis
- CHABiotech
- ElevateBio
- Fate Therapeutics
- Mesoblast (MSCs)
