History

2024

Approval by the U.S. FDA for Phase II clinical trial of “Cord Blood Therapy for Acute Ischemic Stroke.”
Approval by Taiwan FDA for Phase I clinical trial of “Cord Blood Therapy for Cerebral Palsy.”
U.S. FDA approval for Phase II clinical trial of “Cord Blood RegeneCyte Therapy for Long COVID Syndrome,” with all visits completed.

2023

U.S. FDA approval to initiate patient recruitment for Phase II clinical trial of “Cord Blood RegeneCyte Therapy for Long COVID Syndrome.”
Taiwan FDA approval for Phase I clinical trial of “Cord Blood Therapy for Acute Ischemic Stroke,” with all visits completed.
Case report of “Cord Blood RegeneCyte combined with peripheral blood stem cells for the treatment of HIV and acute leukemia” published in the top-tier journal Cell.
Completion of a clinical case study in collaboration with Chung-Ho Memorial Hospital on “Mesenchymal Stem Cell Therapy for Hypoxic-Ischemic Encephalopathy.”

2022

Submission of a Biologic License Application (BLA) to the U.S. FDA for “Cord Blood RegeneCyte Therapy for Hematological Diseases.”
Completion of the world’s first clinical case in collaboration with Taipei Medical University, using three units of cord blood to treat cerebral palsy in an adult patient.

2021

Case study results of the Phase I clinical trial of “Cord Blood Therapy for Acute Ischemic Stroke” published in the international medical journal Cell Transplantation.
U.S. and Taiwan FDA approval to initiate patient recruitment for Phase II multi-center clinical trial of “MC001 Therapy for Chronic Spinal Cord Injury.”

2019

Approval by Taiwan FDA to initiate patient recruitment for Phase I clinical trial of “Cord Blood Therapy for Acute Ischemic Stroke.”

2016

Results of Phase I/II clinical trials of “MC001 Therapy for Chronic Spinal Cord Injury” published in the international medical journal Cell Transplantation.

2015

Achieved 2,000 cord blood transplantations globally.

2014

Completion of Phase I/II clinical trials for “MC001 Therapy for Chronic Spinal Cord Injury.

2013

StemCyte Biotech established in the Cayman Islands.
StemCyte USA participated in the NIH-led international HIV clinical trial collaboration, IMPAACT P1107.
Recognized as a technology enterprise by Taiwan’s Ministry of Economic Affairs.

2012

Completion of Phase II clinical trials for “Autologous Peripheral Blood Stem Cell Therapy for Chronic Stroke.

2010

IRB approval to conduct Phase I/II clinical trials of “Cord Blood MC001 Therapy for Chronic Spinal Cord Injury.”

2009

StemCyte USA laboratory received certification from the American Society for Histocompatibility and Immunogenetics (ASHI).

2008

StemCyte India was established in India.

2007

Assisted in Taiwan’s first private cord blood transplant, where a younger brother successfully saved his older sibling.
Ranked 6th among the 50 fastest-growing tech companies in Deloitte Los Angeles.

2006

Accredited by the Foundation for the Accreditation of Cellular Therapy (FACT).
Collaborated with the U.S. Health Resources and Services Administration (HRSA) to support the National Cord Blood Inventory (NCBI) collection program.

2005

Successfully treated 12 pediatric patients with thalassemia using cord blood, leading to Taiwan’s Department of Health approving cord blood transplantation as a standard therapy for hematological diseases.
Completed Taiwan’s first successful cord blood transplant for osteopetrosis (marble baby syndrome).
Achieved Taiwan’s youngest successful cord blood transplant case in a patient under two months old.

2004

Conducted Taiwan’s first successful multiple-unit cord blood transplant for leukemia.
Completed Taiwan’s first successful cord blood transplant for severe combined immunodeficiency syndrome (SCID).

2003

Successfully treated Taiwan’s first case of severe thalassemia using cord blood transplantation.

2002

Received AABB accreditation for cord blood banking.
Provided Taiwan’s first cord blood unit for transplantation in Singapore.
Became one of the world’s major public cord blood banks, with an inventory exceeding 20,000 units.

2001

Began public cord blood collection in Taiwan.

2000

Began cord blood collection and banking services in California, USA.
StemCyte Taiwan was established.

1998

Developed cord blood storage technology and established standard operating procedures (SOP) for cord blood banking.

1997

StemCyte, Inc. was founded in California, USA.

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