News about Clinical Capabilities
Joint Research Agreement with Keio University on Tumor-Infiltrating Lymphocyte Therapy for Cervical Cancer
We are pleased to announce that REPROCELL has entered into a joint research agreement with Keio University regarding “transfer of technology for the production of Tumor Infiltrating Lymphocytes (TIL) for Advanced Medicine B - a phase II clinical trial for patients with cervical cancer with TIL therapy and low-dose interleukin-2".
Lantern Pharma Selects REPROCELL USA to Provide Support for the Phase 2 Harmonic™ Clinical Trial
REPROCELL USA, a CRO, has been awarded a contract to provide support for Lantern Pharma’s Phase 2 clinical trial entitled “A Study of LP-300 With Carboplatin and Pemetrexed in Never Smokers with Advanced Lung Adenocarcinoma (HARMONIC)”. The Harmonic™ study is being conducted to determine clinical advantages for Lantern Pharma’s investigational new drug LP-300 in combination with carboplatin and pemetrexed in patients who are never smokers with lung adenocarcinoma and have relapsed after treatment with tyrosine kinase inhibitors (TKIs).
REPROCELL Inc. and JTB Corp. form a business alliance to provide Personal iPS Service to domestic and overseas customers
Yokohama, Japan, 13 October 2022: REPROCELL Inc. and JTB Corp. will begin marketing "Personal iPS" (REPROCELL's iPSC storage and production service) overseas through the Japan Medical & Health Tourism Center (JMHC): a medical coordination division established by JTB.
REPROCELL Inc. and CIRM sign MOU for special access to clinical iPSCs
Yokohama Japan, 5 October 2022: REPROCELL Inc. has agreed to join the California Institute for Regenerative Medicine’s (CIRM) Industry Resource Partner Program to make accessible REPROCELL’s unique induced Pluripotent Stem Cells (iPSCs) technology to CIRM Awardees.
REPROCELL and BioBridge Global sign Memorandum of Understanding to accelerate global manufacturing services using clinical iPSCs
YOKOHAMA, Japan: REPROCELL Inc. and San Antonio, Texas-based BioBridge Global have signed a Memorandum of Understanding to enhance their strategic collaborative relationship.
Bioserve India granted NABL accreditation in the field of Genomics Testing
Hyderabad, India - 9 August 2022: We are pleased to announce that Bioserve Biotechnologies India Pvt Ltd, a subsidiary of REPROCELL Inc, has received NABL (National Accreditation Board for Testing and Calibration Laboratories) accreditation for Medical Testing in the field of Genomics Testing Services. The accreditation is in accordance with ISO 15189: 2012 “Medical laboratories - Requirements for quality and competence”.
Completion of Clinical Phase II Trials of Stemchymal in Japan
Yokohama Japan, 16 May 2022: We are pleased to announce that the Clinical Phase II Trial of Stemchymal, a regenerative medicine product derived from somatic stem cells, has been completed in Japan. Previously, on 24 May 2021, we announced that administrations of Stemchymal had been completed for all patients enrolled for the treatment of spinocerebellar ataxia. After data collection, we will unblind the allocation information for the blinded treatment/placebo group (i.e., code-break), conduct data analysis and evaluation, and prepare for submission for approval.
REPROCELL signs agency agreement with Ajinomoto Group for the marketing and sales of StemFit Basic03 GMP
Yokohama Japan, 8 November 2021: REPROCELL has signed a new agency agreement with Ajinomoto Group for the marketing and sale of StemFit Basic03 GMP and GMP compliant recombinant human bFGF. These clinical-grade products are suitable for cell culture workflows leading to therapeutic applications.
REPROCELL signs Strategic Collaboration Agreement with TEXCELL to boost its GMP iPSC - Master Cell Bank Manufacturing Service
Yokohama Japan, 02 September 2021: REPROCELL have signed a Strategic Collaboration Agreement with TEXCELL JAPAN, a TEXCELL Group Company, for GMP iPSC - Master Cell Banks (MCB) Manufacturing. The TEXCELL Group (hereinafter “TEXCELL”) is a contract manufacturing organization (CMO) headquartered in France and managed by the holding company SOPARBIOTECH INTERNATIONAL.
REPROCELL's solution for GMP iPSC development - Seed iPSC Manufacturing Suite
Maryland, USA: REPROCELL has opened a new Seed iPSC Manufacture Suite (SiMS) in response to increasing demand for iPSC-derived Master Cell Banks (MCBs).
Completion of administration of Stemchymal to all enrolled patients in phase II clinical trial in Japan
We are pleased to announce that administrations of Stemchymal, a regenerative medicine product derived from somatic stem cells, have been completed to all enrolled patients in phase II clinical trial for the treatment of spinocerebellar ataxia in Japan. The safety and efficacy of Stemchymal will continue to be investigated during a certain observation period.
VIROCLINICS-DDL announces renewal of collaboration agreement with REPROCELL
Rotterdam, the Netherlands, VIROCLINICS-DDL is pleased to announce the signing of a renewal for collaboration agreement with REPROCELL. REPROCELL will provide sample processing services to VIROCLINICS-DDL to support several clinical research projects.
19 April 2021 – Bioserve Biotechnologies India Pvt. Ltd. launches clinical oncology diagnostic services in India.
Hyderabad India – 19 April 2021: Bioserve Biotechnologies India Pvt Ltd, a 100% owned subsidiary of REPROCELL Inc, is pleased to announce the launch of clinical oncology diagnostic service in India. This new service is clinician-friendly, aiming to deliver comprehensive, NGS-based genomic profiling in oncology targeting a wide range of cancers. The company also provides pharmacogenomics testing using single gene panels, offering researchers detailed interpretations and recommendations that provide powerful insights for the development of targeted therapies.
Launch of New Testing Service of Identification for Covid-19 Variants
We are pleased to announce that on Tuesday 6th April 2021, REPROCELL launched a new testing service for the identification for Covid-19 variants using the Allplex SARS-CoV-2 Variants I Assay (referred to below as Allplex) manufactured by Seegene Inc. (South Korea). This will be offered in addition to full screening test for Covid-19 using cutting-edge SmartAmp technology that REPROCELL launched on March 1st 2021.
REPROCELL collaborates with Blacktrace Holdings in the sales of Nadia series, single-cell analysis system, in Japan
YOKOHAMA, 22 March, 2021/ REPROCELL has initiated a collaboration with Blacktrace Holdings Ltd in the sales of their Nadia series: a single-cell analytical system, in Japan.
REPROCELL Regenerative Medicine Center officially certified as a manufacturing facility for cell culture products
YOKOHAMA, March 16, 2021/ We are pleased to announce that our cell processing facility, REPROCELL Regenerative Medicine Center (located in Life Innovation Center in the Kanagawa region), was certified as manufacturing facility for cell culture products (registration number: FA3200006) on March 8th, 2021 by Kanto-Shinetsu Regional Bureau of Health and Welfare.
Bioserve Biotechnologies India Pvt. Ltd. launches NIPT clinical services in India
Hyderabad India – 11 March 2021: Bioserve Biotechnologies Pvt Ltd, 100% owned subsidiary of REPROCELL Inc, is pleased to announce the launch of Non-Invasive Prenatal Testing (NIPT) services in India.
REPROCELL launches PCR Testing Service for COVID-19
[Yokohama, Japan] REPROCELL will launch a new PCR testing service for COVID-19 from March 2021 in collaboration with DNAFORM Inc: a Japanese start-up company based on cutting-edge technologies developed by RIKEN, Japan’s largest comprehensive research institute.
REPROCELL completes patient registration for phase II clinical trial of regenerative therapeutic Stemchymal®
All patients have been registered at ten sites in Japan for the Phase II clinical trial of Stemchymal®, a human adipose-derived stem cell product exclusively licensed in Japan by Steminent Biotherapeutics Inc. (hereinafter referred to as Steminent), where the safety and efficacy of the regenerative therapeutic will be evaluated in patients with spinocerebellar ataxia (SCA).
REPROCELL launches personalized iPSC production service alongside new B2C website for "Personal iPS" customers
17 December 2020 [Japan, Yokohama]: REPROCELL has announced that they will launch a new service to generate individual specific induced pluripotent stem cell (iPSC) in January, “Personal iPS” service. REPROCELL will start taking orders from January 2021 in Japan. REPROCELL has also launched a new B2C website to promote the Personal iPS service, which is currently only available in Japan.
REPROCELL and VIROCLINICS-DDL Launch New Collaboration in Clinical Research
Rotterdam, The Netherlands, VIROCLINICS-DDL is pleased to announce the signing of a new collaboration agreement with REPROCELL. REPROCELL will provide sample processing services to VIROCLINICS-DDL to support several clinical research projects.
REPROCELL’s Personal iPS Service is Launched in Japan
Yokohama, Japan: REPROCELL is delighted to announce the launch a new service for consumers, Personal iPS, in which induced pluripotent stem cells (iPSCs) re established for future regenerative medicine treatment.
Phase II clinical trial of regenerative medicine product Stemchymal® - Recruitment of first patient
REPROCELL is pleased to announce that the first patient has been registered and the test article administered at Nagoya University in the Phase II clinical trial of the regenerative medicine product Stemchymal®.