Available Products


A comprehensive list of current cell and gene therapy products available in different markets across the world. 


A comprehensive list of current cell and gene therapy products available in different markets across the world. 

This page lays out approved cell, gene, and tissue-engineered therapies, including approved regions and a summary of approved indications (diseases and conditions). Details such as pediatric vs. adult use, year approved, previous lines of treatment needed, and recent approvals/changes are not necessarily reflected. If you have questions about or suggested edits/additions to this list, please contact Adam Wolf.

This list, though not exhaustive, exclusively includes those products that have undergone the necessary scientifically-based, rigorous regulatory approval process, including in-human clinical trials where appropriate, overseen by internationally-recognized regulatory agencies, such as the U.S. FDA; the EU’s European Medicines Agency; Japan’s Pharmaceuticals and Medical Devices Agency; South Korea’s Ministry of Food and Drug Safety, among others.

Cell-Based Immunotherapy Products

Abecma
bluebird bio

Abecma is a chimeric antigen receptor (CAR) T-cell therapy for adults with relapsed or refractory multiple myeloma.

Approved in: The United States, Canada, Japan, and the European Union

Approved for: R/R multiple myeloma

APCeden
APAC Biotech

APCeden is an autologous monocyte-derived mature dendritic cell vaccine.

Approved in: India

Approved for: Treatment of prostate cancer, ovarian cancer, colorectal cancer, and Non Small Cell Lung carcinoma

Breyanzi
Bristol Myers Squibb

Breyanzi is a CAR T-cell therapy for adults with relapsed or refractory large B-cell lymphoma.

Approved in: The United States and the European Union

Approved for: R/R large B-cell lymphoma, R/R diffuse large B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B

Carteyva
JW Therapeutics

Carteyva is an autologous anti-CD19 CAR-T cell immunotherapy drug.

Approved in: China

Approved for: R/R large B-cell lymphoma

Carvykti
Legend Biotech & Janssen

Carvykti is a CAR-T cell therapy used for adult patients who have cancer of the bone marrow called multiple myeloma.

Approved in: The United States and the European Union

Approved for: R/R multiple myeloma

CreaVax RCC
JW CreaGene

CreaVax RCC is a dendritic cell based vaccine.

Approved in: Republic of Korea

Approved for: Treatment of metastatic renal cell carcinoma for which nephrectomy can be performed

Ebvallo
Atara Biotherapeutics

Ebvallo is an allogeneic T-cell immunotherapy used to treat adult and pediatric patients two years of age and older with relapsed or refractory Epstein‑Barr virus positive post‑transplant lymphoproliferative disease. (EBV+ PTLD)

Approved in: The European Union

Approved for: Epstein‑Barr virus positive post‑transplant lymphoproliferative disease (EBV+ PTLD)

Immuncell-LC
GC Pharma

Immuncell-LC is a medicine for anticancer cell immunotherapy, made with T-lymphocyte incubated and activated after extraction from the blood of a patient.

Approved in: Republic of Korea

Approved for: Liver cancer (hepatocellular carcinoma)

Inaticabtagene Autoleucel
CASI Pharmaceuticals Inc.

Inaticabtagene Autoleucel is a CAR-T cell therapy for the treatment of relapsed and refractory B-cell acute lymphoblastic leukemia. (r/r B-ALL)

Approved in: China

Approved for: R/R B-cell acute lymphoblastic leukemia

Kymriah
Novartis

Kymriah is a CAR T-cell therapy product to treat R/R follicular lymphoma.

Approved in: The United States, the European Union, Canada, Japan, and Singapore.

Approved for: B-cell acute lymphoblastic leukemia, chronic lymphoid leukemia, diffuse large B-cell lymphoma, R/R large B-cell lymphoma, and R/R follicular lymphoma

Provenge
Dendreon

Provenge is an autologous cellular immunotherapy.

Approved in: The United States

Approved for: Asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer

Tecartus
Kite, a Gilead Company

Tecartus is a CAR-T therapy designed to treat mantle cell lymphoma.

Approved in: The United States and the European Union

Approved for: Mantle cell lymphoma and B-cell precursor acute lymphoblastic leukemia

Yescarta
Kite, a Gilead Company

Yescarta is a CAR T-cell therapy product.

Approved in: The United States, the European Union, Canada, Japan, and China

Approved for: B cell malignancies such as non-Hodgkin lymphoma, R/R follicular lymphoma, acute lymphoblastic leukemia, mantle cell lymphoma, chronic lymphoid leukemia, R/R large B-cell lymphoma and diffuse large B-Cell lymphoma

 

Gene Therapy Products

Adstiladrin
Ferring Pharmaceuticals

Adstiladrin is a adenoviral vector-based gene therapy used to treat adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.

Approved in: The United States

Approved for: High-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ

Casgevy
Vertex Pharmaceuticals and CRISPR Therapeutics

Casgevy is a CRIPSR gene editing therapy to treat sickle-cell disease and β-thalassaemia.

Approved in: The United Kingdom and Bahrain

Approved for: Sickle-cell disease and β-thalassaemia

Collategene
AnGes

Collategene is a gene therapy consisting of an intramuscular injection of plasmid (DNA) coding for Hepatocyte Growth Factor (HGF), intended to grow blood vessels.

Approved in: Japan

Approved for: Critical limb ischemia

Elevidys
Sarepta Therapeutics

Elevidys is an adeno-associated virus-based gene therapy for the treatment of ambulatory pediatric patients aged 4 through 5 years with Duchenne muscular dystrophy (DMD) with a confirmed mutation in the DMD gene.

Approved in: The United States

Approved for: Duchenne Muscular Dystrophy in patients aged 4 through 5.

Gendicine
Shenzhen SiBiono GeneTech

Gendicine is a recombinant adenovirus engineered to express wildtype-p53 (rAd-p53), designed to treat patients with tumors which have mutated p53 genes. Gendicine is the first gene therapy product approved for clinical use in humans.

Approved in: China

Approved for: Head and neck squamous cell cancer

Hemgenix
UniQure and CSL Behring

Hemgenix is an adeno-associated virus vector-based gene therapy to treat adults with Hemophilia B.

Approved in: The European Union, the United Kingdom and the United States

Approved for: Hemophilia B

Imlygic
Amgen

Imlygic is a weakened form of Herpes Simplex Virus Type 1, which is commonly called the cold sore virus.

Approved in: The United States, the European Union, and Australia

Approved for: Unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery

Libmeldy
Orchard Therapeutics

A lentiviral vector-based gene therapy for the treatment of metachromatic leukodystrophy (MLD).

Approved in: The European Union

Approved for: Metachromatic leukodystrophy (MLD)

Luxturna
Spark Therapeutics

Luxturna is an adeno-associated viral vector gene therapy.

Approved in: The United States, the European Union, and Canada

Approved for: RPE65-mediated inherited retinal dystrophies

Roctavian
BioMarin

Roctavian is a gene therapy for the treatment of severe hemophilia A in adult patients.

Approved in: The European Union and the United States

Approved for: Hemophilia A

Skysona
bluebird bio

Skysona is gene therapy made using a genetically modified autologous CD34+ cell-enriched population that contains hematopoietic stem cells.

Approved in: The United States

Approved for: Active cerebral adrenoleukodystrophy (CALD)

Strimvelis
GSK

Strimvelis is an ex-vivo stem cell gene therapy which uses retroviral vector encoding adenosine deaminase gene transfer into hematopoietic stem/progenitor cells.

Approved in: The European Union

Approved for: Adenosine deaminase severe combined immune deficiency

Upstaza
PTC Therapeutics

Upstaza is a gene therapy used to treat severe aromatic L-amino acid decarboxylase (AADC) deficiency.

Approved in: The European Union

Approved for: Aromatic L‑amino acid decarboxylase (AADC) deficiency

VYJUVEK
Krystal Biotech

VYJUVEK is a redosable gene therapy to treat dystrophic epidermolysis bullosa.

Approved in: The United States

Approved for: Dystrophic epidermolysis bullosa

Zolgensma
Novartis Gene Therapies

Zolgensma (onasemnogene abeparvovec-xioi) is an adeno-associated virus vector-based gene therapy.

Approved in: The United States, Japan, the European Union, Canada, Australia, and the Republic of Korea

Approved for: Spinal muscular atrophy (SMA)

Zynteglo
bluebird bio

Zynteglo is an ex-vivo lentiviral based gene therapy used to provide a functional copy of the the β-globin gene into a patient’s hematopoietic (blood) stem cells.

Approved in: The United States (Withdrawn in the European Union in 2021)

Approved for: ß-thalassemia who require regular red blood cell (RBC) transfusions

Cell Therapy Products

Alofisel
TiGenix

Alofisel is an allogeneic stem cell therapy to treat complex perianal fistulas in patients with Crohn’s disease.

Approved in: The European Union

Approved for: Complex perianal fistulas in patients with Crohn’s disease

Cartistem
MEDIPOST

Cartistem is a cellular therapeutic agent containing allogeneic human umbilical cord blood-derived mesenchymal stem cells.

Approved in: Republic of Korea

Approved for: Knee cartilage defects such as traumatic articular cartilage, degenerative arthritis and rheumatoid arthritis

Cellgram-AMI
FCB Pharmicell

Cellgram-AMI is an autologous intracoronary bone marrow-derived mesenchymal stem cell injection for the treatment acute myocardial infarction.

Approved in: Republic of Korea

Approved for: Acute myocardial infarction

Cupistem
Anterogen

Cupistem is an autologous adipose derived mesenchymal stem cell treatment to reduce inflammation and regenerate damage joint tissues.

Approved in: Republic of Korea

Approved for: Crohn’s fistula

CureSkin
S. Biomedics

CureSkin is an autologous dermal fibroblast cell-based therapy.

Approved in: Republic of Korea

Approved for: Treatment of depressed acne scars

FUCASO
Innovent Biologics & IASO Biotechnology

FUCASO is a BCMA CAR-T therapy for the treatment of relapsed or refractory multiple myeloma.

Approved in: China

Approved for: Relapsed or refractory multiple myeloma.

Holoclar
Chiesi Farmaceutici

Holoclar is a cell therapy based on autologous cultures of limbal stem cells. It regenerates a functional corneal epithelium allowing recovery of visual acuity.

Approved in: The European Union

Approved for: Moderate to severe limbal stem cell deficiency due to ocular burns

Kaloderm
Tego Sciences

Kaloderm is an allogeneic cell therapy for deep second degree burns and diabetic foot ulcers.

Approved in: Republic of Korea

Approved for: Burns and diabetic foot ulcers

KeraHeal
BioSolutions

KeraHeal is an autologous keratinocyte based cell therapy.

Approved in: Republic of Korea

Approved for: Treatment of 2nd degree burns

KeraHeal-Allo
BioSolutions

KeraHeal-Allo is a hydrogel-type allogeneic keratinocyte therapy product.

Approved in: Republic of Korea

Approved for: Treatment of second-degree burns.

Lantidra
CellTrans

Lantidra is an allogeneic (donor) pancreatic islet cellular therapy made from deceased donor pancreatic cells for the treatment of type 1 diabetes.

Approved in: The United States

Approved for: Adults with type 1 diabetes who are unable to approach target glycated hemoglobin (average blood glucose levels)

LaViv (Azficel-T)
Fibrocell Technologies

LaViv is an autologous fibroblast-based cell therapy.

Approved in: United States

Approved for: Improvement of the appearance of moderate to severe nasolabial fold wrinkles in adults

Neuronata-r
Corestem

Neuronata-r is an autologous bone marrow mesenchymal stem cell.

Approved in: Republic of Korea

Approved for: Amyotrophic lateral sclerosis (ALS)

Omisirge
Gamida Cell

Omisirge is a NAM-enabled stem cell therapy for hematologic malignancies that are planned for umbilical cord blood transplantation following myeloablative conditioning to reduce the time to neutrophil recovery and the incidence of infection.

Approved in: The United States

Approved for: Hematologic malignancies

Queencell
Anterogen

Queencell is an autologous mesenchymal stem cell for the treatment of connective tissue disorders.

Approved in: Republic of Korea

Approved for: Connective tissue disorders

Rosmir
TEGO Science

Rosmir is autologous cell therapy.

Approved in: Republic of Korea

Approved for: Treatment of under eye wrinkles

Spherox (formerly Chrondosphere)
CO.DON AG

Spherox is a product containing spheroids of human autologous chondrocytes for use in cartilage defects.

Approved in: The European Union

Approved for: Cartilage defects

Stemirac
Nipro Corp

Stemirac is a mesenchymal stem cell therapy.

Approved in: Japan

Approved for: Treatment of spinal cord injury

Stempeucel
Stempeutics Research Pvt

Stempeucel is an ex-vivo cultured adult allogeneic mesenchymal stromal cell therapy.

Approved in: India

Approved for: Critical Limb Ischemia

TEMCELL
JCR Pharmaceuticals Co Ltd, licensee of Mesoblast Ltd

TEMCELL is an allogeneic mesenchymal stem cell product.

Approved in: Japan, Canada and New Zealand

Approved for: Acute radiation injury, chronic obstructive pulmonary disease, Crohn’s disease, acute graft-versus-host disease, Type I diabetes and myocardial infarction

Vyznova
Aurion Biotech

Vyznova is a cell therapy for the treatment of bullous keratopathy of the cornea.

Approved in: Japan

Approved for: Bullous keratopathy of the cornea

Cord Blood Therapies

CLEVECORD (HPC Cord Blood)
Cleveland Cord Blood Center

CLEVECORD is used for unrelated donor hematopoietic progenitor cell transplantation procedures in conjunction with an appropriate preparative regimen for hematopoietic and immunologic reconstitution in patients with disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment.

Approved in: The United States

Approved for: Unrelated donor hematopoietic progenitor cell transplantation procedures

HPC Cord Blood
Bloodworks

HPC Cord Blood is used for hematopoietic progenitor cell transplantation procedures in conjunction with an appropriate preparative regimen for hematopoietic and immunologic reconstitution in patients with disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment.

Approved in: The United States

Approved for: Unrelated donor hematopoietic progenitor cell transplantation procedures

HPC Cord Blood
MD Anderson Cord Blood Bank

HPC Cord Blood is used in unrelated donor hematopoietic progenitor cell transplantation procedures in conjunction with an appropriate preparative regimen for hematopoietic and immunologic reconstitution in patients with disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment.

Approved in: The United States

Approved for: Unrelated donor hematopoietic progenitor cell transplantation procedures

Hemacord (HPC Cord Blood)
New York Blood Center

Hemacord is used for unrelated donor hematopoietic progenitor cell transplantation procedures in conjunction with an appropriate preparative regimen for hematopoietic and immunologic reconstitution in patients with disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment.

Approved in: The United States

Approved for: Unrelated donor hematopoietic progenitor cell transplantation procedures

Allocord (HPC Cord Blood)
SSM Cardinal Glennon Children's Medical Center

Allocord is an allogeneic cord blood hematopoietic progenitor cell therapy indicated for use in unrelated donor hematopoietic progenitor cell transplantation procedures in conjunction with an appropriate preparative regimen for hematopoietic and immunologic reconstitution in patients with disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment.

Approved in: The United States

Approved for: Unrelated donor hematopoietic progenitor cell transplantation procedures

Ducord (HPC Cord Blood)
Duke University Medical Center

Ducord is an allogeneic cord blood hematopoietic progenitor cell therapy indicated for use in unrelated donor hematopoietic progenitor cell transplantation procedures in conjunction with an appropriate preparative regimen for hematopoietic and immunologic reconstitution in patients with disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment.

Approved in: The United States

Approved for: Unrelated donor hematopoietic progenitor cell transplantation procedures

HPC Cord Blood
Clinimmune

Clinimmune’s HPC Cord Blood is an allogeneic cord blood hematopoietic progenitor cell therapy indicated for use in unrelated donor hematopoietic progenitor cell transplantation procedures in conjunction with an appropriate preparative regimen for hematopoietic and immunologic reconstitution in patients with disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment.

Approved in: The United States

Approved for: Unrelated donor hematopoietic progenitor cell transplantation procedures

HPC Cord Blood
Life South

Life South’s HPC Cord Blood is an allogeneic cord blood hematopoietic progenitor cell therapy indicated for use in unrelated donor hematopoietic progenitor cell transplantation procedures in conjunction with an appropriate preparative regimen for hematopoietic and immunologic reconstitution in patients with disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment.

Approved in: The United States

Approved for: Unrelated donor hematopoietic progenitor cell transplantation procedures

Tissue-Engineered Products

Aurix
Nuo Therapeutics

Aurix is a biodynamic hematogel composed of platelet-rich plasma gel prepared from a small sample of a patient’s own platelets and plasma as a catalyst for healing indicated for the treatment of wounds.

Approved in: The United States

Approved for: Treatment of wounds

Apligraf
Organogenesis, Inc. & Novartis AG

Apligraf is a bi-layered living skin substitute made from a dermal layer of human cells (fibroblasts) in a bovine type I collagen and an overlying cornified epidermal layer of living human keratinocytes.

Approved in: The United States

Approved for: Treatment of chronic venous leg ulcers and diabetic foot ulcer

CardioCel
Admedus

CardioCel is a cardiovascular scaffold which facilitates endogenous stem cells and other cells to regenerate and repair damaged tissue for the treatment of cardiovascular abnormalities.

Approved in: The United States, the European Union, Canada, and Singapore

Approved for: Treatment of cardiovascular abnormalities

Dermagraft
Organogenesis

Dermagraft is a dermal substitute used to help in the wound closure of diabetic foot ulcers. It is made from human cells (fibroblasts), placed on a dissolvable mesh material.

Approved in: The United States

Approved for: Chronic foot ulcers in patients with diabetes

Epicel
Vericel

Epicel is a permanent skin replacement product grown from a patient’s own skin cells. The autologous keratinocytes are co-cultured with irradiated murine cells to form cultured epidermal autografts (CEA).

Approved in: The United States

Approved for: Deep dermal or full thickness burns

Heart Sheet
Terumo BCT

Heart Sheet is an autologous skeletal myoblast preparation.

Approved in: Japan

Approved for: Treatment of patients with serious heart failure

Holoderm
Tego Sciences

Holloderm is a cultured epidermal autograft composed by culturing autologous keratinocytes. It is transplanted to the wound and aids in regeneration of the dermis and develops into new skin.

Approved in: Republic of Korea

Approved for: Treatment of skin disorders such as burns, vitiligo, nevi and scars

Hyalograft 3D
CHA Bio&Diostech Co Ltd

Hyalograft 3D is a cell therapy which cultivates autologous skin fibroblasts in 3D scaffolds formed of hyaluronic acid derivatives for the treatment of diabetic foot ulcers.

Approved in: Republic of Korea

Approved for: Diabetic foot ulcers

JACC
J-TEC

JACC is a combination product of autologous cultured chondrocytes and collagen gel.

Approved in: Japan

Approved for: Traumatic cartilage defect or osteochondritis dissecans of the knee

JACE
J-TEC

JACE is an epidermal cell sheet produced from keratinocytes isolated from a patient’s own skin tissue.

Approved in: Japan

Approved for: Deep dermal and full-thickness burns covering 30% or more of the total body surface area; and treatment of giant congenital melanocytic nevi

MACI
Autologous Cultured Chondrocytes on a Porcine Collagen Membrane / Vericel

MACI is an autologous cellularized scaffold product, indicated for the repair of single or multiple symptomatic, full-thickness cartilage defects of the knee with or without bone involvement in adults.

Approved in: The United States

Approved for: Single or multiple symptomatic, full-thickness cartilage defects of the knee

Novocart 3D
Aesculap Biologics

Novocart 3D consists of three-dimensional collagen-chondroitin sulphate scaffolds with embedded autologous chondrocytes in a cell suspension.

Approved in: The European Union

Approved for: Articular cartilage repair

Omnigraft
Integra

An advanced bilayer dermal regeneration matrix for the treatment of diabetic foot ulcers.

Approved in: The United States

Approved for: Diabetic foot ulcers

Ortho-ACI
Orthocell

Ortho-ACI is an autologous chondroctye-based cellularized scaffold to treat symptomatic defects of the articulating cartilage of the joints, predominately the knee and ankle.

Approved in: Australia

Approved for: Symptomatic defects

Ossron

Ossron is an autologous bone cell implantation for the treatment of bone defects in patients caused by degeneration, drugs, intense physical stress, diet, genetics, obesity, smoking, alcohol or disease.

Approved in: Republic of Korea and India

Approved for: Bone defects

ReGenerCel
Avita Medical

An autologous cell harvesting device that enables a to create a regenerative epithelial suspension using the sample of the patient’s skin for the treatment of ulcers.

Approved in: The European Union

Approved for: Treatment of ulcers

ReNovaCell
Avita Medical

ReNovaCell is an autologous cell harvesting device that enables a to create a regenerative epithelial suspension using the sample of the patient’s skin for the treatment of skin discoloration.

Approved in: The European Union

Approved for: Treatment of skin discoloration

Rethymic
Enzyvant

Rethymic is a one-time tissue therapy to treat immune reconstitution in pediatric patients with congenital athymia.

Approved in: The United States

Approved for: Immune reconstitution in patients with congenital athymia

Stratagraft
Mallinckrodt

Startagraft (Allogeneic cultured keratinocytes and dermal fibroblast in murine collgen-dsat) is a allogeneic cellularized scaffold product.

Approved in: The United States

Approved for: Deep partial-thickness burns

Transcyte
Organogenesis

Transcyte is a tissue-engineered skin substitute made from a nylon mesh and a silastic semi permissible and biocompatible layer.

Approved in: The United States

Approved for: The treatment of Epidermolysis Bullosa

Vergenix FG
CollPlant

Vergenix FG is a device composed of homogenous human recombinant type I collage for use in wound treatment.

Approved in: The European Union

Approved for: Wound treatment

Vergenix-STR
CollPlant

Vergenix-STR is a matrix made of collagen type I for use in the treatment of connective tissue disorders.

Approved in: The European Union

Approved for: Treatment of connective tissue disorders