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중간엽 줄기세포 : 진보와 응용(2021년)

Mesenchymal Stem Cells - Advances and Applications, 2021

리서치사 BIOINFORMANT WORLDWIDE, LLC
발행일 2021년 02월 상품 코드 986212
페이지 정보 영문 276 Pages
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중간엽 줄기세포 : 진보와 응용(2021년) Mesenchymal Stem Cells - Advances and Applications, 2021
발행일 : 2021년 02월 페이지 정보 : 영문 276 Pages

본 상품은 영문 자료로 한글과 영문목차에 불일치하는 내용이 있을 경우 영문을 우선합니다. 정확한 검토를 위해 영문목차를 참고해주시기 바랍니다.

현재 재생의료에서 사용되고 있는 가장 일반적인 줄기세포 유형으로서 중간엽 줄기세포(MSC) 시장 내에서의 성장 가능성이 큽니다. MSC에 대해서는 10만개 이상의 과학 출판물이 발표되었고, 전세계적으로 1,100건 이상의 MSC 임상시험이 진행되고 있습니다. MSC 임상시험의 현재 핫스팟에는 미국, EU, 중국, 중동, 한국이 포함됩니다. 많은 초기 단계 MSC 시험에서 안전성과 유효성이 입증되었으나, 상품화된 MSC 제품은 극소수이며, MSC 치료 시장은 여전히 초기 단계임을 나타내고 있습니다. 인구 고령화와 만성질환 유병률 증가 또한 MSC 기반 치료에 대한 관심을 높이고 있습니다. Google Trend의 데이터에 의하면, MSC 검색은 다음으로 일반적인 줄기세포 타입의 2배 이상 일반적입니다. 최근 MSC와 MSC 기반 조사 제품 양쪽 모두 수요가 급증하고 있습니다.

세계의 중간엽 줄기세포(MSC: Mesenchymal Stem Cell) 시장에 대해 조사했으며, 주요 기업 98개사의 활동에 대해 상세하게 분석했으며, 5년간 시장 예측, 지역·사업 부문별 시장 규모 상세 데이터를 제공합니다.

목차

제1장 보고서 개요

  • 보고서 설명
  • 타겟 인구통계
  • 보고서의 출처
  • 보고서의 목적
  • 개요
  • 서론

제2장 중간엽 줄기세포(MSCS) : 개요

  • 재생의료에 대한 MSC의 영향
  • MSC 명명법 타임라인
  • MSC의 소스
    • 골수 유래 MSC(BM-MSC)
    • 지방 유래 MSC(AD-MSC)
    • 탯줄 유래 MSC(UC-MSC)
  • MSC의 세포 표면 마커
  • MSC의 인비트로 분화능
  • MSC별 분비되는 가용성 요인

제3장 중간엽 줄기세포 제조

  • MSC의 분리 방법
  • 기존 배양에서 바이오리액터로
    • 단층 배양 시스템
    • 바이오리액터 기반 세포 증식
    • 교반조형 바이오리액터
    • 로킹 바이오리액터
    • 중공사 바이오리액터
    • 고정상 바이오리액터
    • 세포 분리
    • 세포 세정과 농축
    • 안전성과 효력 어세이
    • MSC 제조중의 식별을 위한 표면 마커

제4장 자가 및 동종 MSC 제조 비교

  • 제조원가 비교
    • 비용 차이
    • 기증자 스크리닝과 테스트 비용
    • 릴리스 테스트 비용
  • 2개의 비즈니스 모델 비교
    • 면역 반응 리스크
    • 상호 오염 리스크
    • 상업적으로 매력적인 옵션
  • MSC 제조 비용 분석
  • 비용 절감 기회
  • 부분 자동화와 완전 자동화
    • 부분적인 자동화 : 가장 매력적인 옵션

제5장 MSCS의 소규모 프로세싱

  • 모델 설계
  • 배지

제6장 MSCS의 대규모 확장

  • 대규모 확장을 위한 4개의 일반적인 바이오프로세싱 전략
  • 대규모 확장에 일반적으로 사용되는 MSC 소스
  • MSC 대규모 확장에 일반적으로 사용되는 배지
    • 다른 배지에서 달성된 발포 배율
  • 대규모 바이오프로세싱 전략 비교
  • 세포치료 수탁제조
    • 위탁생산(CMO)
    • 위탁개발 생산(CDMO)
  • 세계의 세포치료 제조능력
    • 미국의 주요 세포치료 CMO/CDMO
    • 유럽의 세포치료 제조를 위한 주요 CMO/CDMO

제7장 업계에서의 MSCS 추정 소비량

  • 학술 및 전임상 환경에서의 MSC 소비
  • 임상 현장에서의 MSC 소비
  • 임상시험 표적 적응증별 MSC 소비
  • 향후의 소비 예측
    • MSC 치료제 소비
    • 인공 조직 및 장기 소비
    • MSC 파생 제품별 MSC 소비
    • 신흥 산업에서의 MSC 소비
  • 임상시험에서 사용되는 환자당 MSC 비용 : 적응증별

제8장 MSCS에서 공개된 과학 논문

  • MSC와 iPSC에 관한 논문수 비교
  • MSC에 관한 논문수 : 소스별
  • MSC를 포함한 임상시험으로 발표된 논문수
    • 특정 질환에 대해 MSC를 사용한 임상시험에 관한 논문수

제9장 MSCS, MSC 기반 COVID-19, MSC-Exosome 임상시험

  • ClinicalTrials.gov에서의 데이터 분석
  • 임상시험을 위한 MSC 소스
  • 자가 MSC와 동종 MSC
  • MSC 기반 임상시험의 지역 분포
    • MSC 기반 임상시험에 참여하고 있는 주요 국가
  • MSC 기반 임상시험을 위한 자금 유형
  • MSC 기반 임상시험 유형
  • 개발 단계별 MSC 기반 임상시험
  • COVID-19 치료를 위한 MSC를 포함한 임상시험
    • MSC 기반 COVID-19 임상시험 : 지역별
  • MSC 유래 엑소좀을 포함한 임상시험
  • MSC 연구를 위한 NIH 자금
  • MSC 프로젝트를 위한 CIRM 자금
    • MSC 기반 임상시험을 위한 CIRM 자금

제10장 현재의 최적 이하 임상 결과&해결책

  • MSC 제조에서 발생하는 과제를 극복하기 위해
    • MSC 제품의 불균일성
  • 동결 보존과 문화 구조
    • MSC의 기능을 높이는 바이오엔지니어링 솔루션
    • 항암제 Trogan Horses를 옮기기 위한 MSC 엔지니어링
  • 주입에 관련된 임상적 과제 극복
    • 지방 행정
    • 불충분한 유지와 생존
    • 지방 행정을 개선하기 위한 전략
  • 호스트에서의 임상적 과제를 극복하기 위해

제11장 MSCS의 변경

  • 유전자 재조합
    • 이동을 개선하기 위한 유전자 재조합
    • 접착을 개선하기 위한 유전자 재조합
    • 생존률을 개선하기 위한 유전자 재조합
    • 조기 노화를 줄이기 위한 유전자 재조합
  • 사전 처리 변경
    • 이동을 개선하기 위한 사전 처리
    • 접착성을 개선하기 위한 사전 처리
    • 생존률을 개선하기 위한 사전 처리
    • 노화를 줄이기 위한 사전 처리
  • 개변 MSC의 치료 응용
    • 신경학적 상태를 위한 개변 MSC
    • 심혈관질환을 위한 개변 MSC
    • 폐손상을 위한 개변 MSC
    • 당뇨병을 위한 개변 MSC

제12장 임상시험에서 MSCS가 대처하는 주요 질환

  • 자가면역질환에 대한 MSC를 사용한 임상시험
  • 심혈관질환에 대한 MSC를 사용한 임상시험
  • 신경변성질환에 대한 MSC를 사용한 임상시험
  • 뼈 및 연골 질환에 대한 MSC를 사용한 임상시험

제13장 중간엽 줄기세포 산업 현황

  • 연구 및 임상 응용을 위한 MSC 소스
  • 견인력을 얻고 있는 동종이계 제품
  • 마케팅 승인이 있는 MSC 기반 제품
    • Alofisel
    • Stemirac
    • Stempeucel
    • Temcell HS
    • Neuronata-R
    • Prochymal(Remestemcel-L)
    • Cupistem
    • Cartistem
    • Cellgram-AMI
    • Queencell
  • 현재 판매되고 있는 MSC 기반 뼈 매트릭스
    • Osteocel
    • AlloStem
    • Cellentra VCBM
    • HiQCell
    • Trinity ELITE
    • Map3
    • Trinity Evolution
    • Carticel
    • Chondron
    • DeNovo NT
    • Chondrocelect
    • Ossron
    • JACC
    • MACI
    • Ortho-ACI
    • Spherox
    • Ossgrow
    • Cartigrow
    • ViviGen
    • Bio4
    • Cartiform
  • 전세포 MSC 요법에서 MSC 유래 엑소좀 요법으로
    • MSC 유래 엑소좀의 이점
    • MSC 유래 엑소좀의 내용
    • 진단으로서의 엑소좀
    • 약물전달 벡터로서의 엑소좀
  • MSC 기반 COVID-19 치료
  • MSC 기반 클린 미트 생산
  • 줄기세포 기반 화장품
    • 시판 줄기세포 기반 화장품

제14장 시장 분석

  • MSC 기반 세포치료(CT) 치료 가격표
  • MSC 기반 매트릭스 가격표
  • MSC 기반 치료법 시장 규모
  • 세계의 MSC 기반 치료제 시장
  • 세계의 중간엽 줄기세포(MSC) 수요
    • 학술 및 전임상 연구에 필요한 MSC
    • 임상시험에 필요한 MSC
    • MSC 기반 치료법 개발에 필요한 MSC
    • MSC 파생 제품 개발에 필요한 MSC
    • 신흥 산업에 필요한 MSC
    • 세계 중간엽 줄기세포 시장 규모
  • MSC 기반 사업 부문의 시장 점유율

제15장 기업 개요

  • 101 Bio
  • Adipomics, Inc.
  • Aegle Therapeutics
  • Aethlon Medical, Inc.
  • AgeX Therapeutics, Inc.
  • Alexerion Biotech Corp.
  • AlloSource, Inc.
  • American CryoStem Corporation
  • American Type Culture Collection(ATCC)
  • AMS Bio, Ltd.(AMSBIO)
  • Anemocyte S.r.l
  • Anjarium Biosciences
  • Anterogen, Co., Ltd.
  • Apceth Biopharma GmbH
  • Assay Development
  • Aruna Bio
  • Athersys, Inc.
  • Avalon GloboCare Corp.
  • Axol Bioscience, Ltd.
  • Azymus Therapeutics
  • BioCat GmbH
  • BioFluidica
  • Bio-Techne
  • BioVision, Inc.
  • Baylx, Inc.
  • BrainStorm Cell Therapeutics
  • Capricor Therapeutics
  • Catalent Pharma Solutions
  • CCRM
  • CellResearch Corporation, Pte Ltd.
  • Celltex Therapeutics Corporation
  • Ciloa
  • Codiak Biosciences
  • Corestem, Inc.
  • CO-DON AG
  • Cognate Bio, Inc.
  • Creative Bioarray
  • Creative Biolabs
  • Cynata Therapeutics, Ltd.
  • DePuy Synthes
  • Direct Biologics
  • EVerZom
  • Evox Therapeutics, Ltd.
  • Exerkine Corp.
  • Clinical Development
  • ExoCan Healthcare Technologies, Pvt. Ltd.
  • ExoCoBio, Co., Ltd.
  • Exogenus Therapeutics
  • EXoPERT
  • Exopharm
  • Exosome Diagnostics, Inc.
  • ExoDx Prostate Test
  • ExosomePlus
  • Exosome Sciences
  • Exosomics S.p.A
  • Fraunhofer Institute for Cell Therapy and Immunology
  • HansaBioMed Life Sciences, Ltd.
  • Hope Biosciences, LLC
  • Hope's Cell Culture Process
  • Japan Tissue Engineering, Co., Ltd.
  • JCR Pharmaceuticals, Co., Ltd.
  • Kimera Labs, Inc.
  • Lonza Group Ltd.
  • Mantra Bio
  • Medipost, Co., Ltd.
  • MDimune
  • NanoSomix, Inc.
  • NanoView Biosciences
  • NeurExo Sciences
  • Nipro Corporation
  • Stemirac
  • Novus Biologicals, LLC
  • Exosomes Research Tools
  • NuVasive, Inc.
  • Osteocel Family
  • OmniSpirant Limited
  • Orthocell, Ltd.
  • Orthofix Medical, Inc.
  • Osiris Therapeutics, Inc.
  • Pharmicell, Co., Ltd.
  • Pluristem Therapeutics, Inc.
  • Regeneus, Ltd.
  • HiQCell
  • Regrow Biosciences, Pvt., Ltd.
  • ReNeuron
  • RoosterBio
  • RoslinCT
  • RTI Surgical, Inc.
  • Sentien Biotechnologies, Inc.
  • STEMCELL Technologies, Inc.
  • Stemedica Cell Technologies, Inc.
  • Stemmatters Biotechnologia e Medicina Regenerative SA
  • Stempeutics Research, Pvt., Ltd.
  • System Biosciences, LLC
  • Takeda Pharmaceuticals U.S.A., Inc.
  • Alofisel
  • Tempo Bioscience
  • Tavec Pharma
  • United Therapeutics Corp.
  • Vericel Corporation
  • Versatope Therapeutics
  • Vesigen Therapeutics, Inc.
  • Waisman Biomanufacturing
  • WuXi Advanced Therapies
  • XOStem, Inc.
  • Zen-Bio, Inc.
  • Zimmer Biomet
LSH 21.02.10

EXECUTIVE SUMMARY

Mesenchymal stem cells (MSCs) are multipotent cells that can differentiate into a variety of cell types, including but not limited to osteoblasts, chondrocytes, myocytes, and adipocytes. In addition to secreting factors that can stimulate tissue repair, MSCs can substantially alter their microenvironment, exerting effects that are both anti-inflammatory and anti-fibrotic. MSCs are advantageous over other stem cells types for a variety of reasons, including that they are immuno-privileged, making them an advantageous cell type for allogenic transplantation. MSCs appear to be an exceptionally promising tool for cell therapy, because of their unusual advantages, which include availability, expandability, transplantability, and ethical implications. Interest in therapeutic applications of human MSCs arises from their diverse ability to differentiate into a range of cell types, as well as their ability to migrate to sites of tissue injury/inflammation or tumor growth.

Naturally, a broad range of research products have been developed around MSCs and their differentiated cell types. Growing attention is also being given to manufacturing technologies to support commercial-scale production of MSCs. MSCs are well-suited for use in the exponential growth field of 3D printing, because of their capacity to form structural tissues. Numerous market competitors are exploring commercialization strategies for MSC-derived extracellular vesicles (Evs) and exosomes, because these extracellular "packages" represent a novel strategy for accessing the therapeutic effects of stem cells without the risks of administering whole cells to patients. Finally, gene editing of MSCs for overexpressing antitumor genes or therapeutic factors is broadening their application.

As the most common stem cell type being used within regenerative medicine today, there is huge potential for growth within the MSC market. There are more than one-hundred thousand scientific publications published about MSCs, as well over 1,100 MSC clinical trials underway worldwide. Current "hotspots" for MSC clinical trials include the U.S., E.U., China, Middle East, and South Korea. While many early-stage MSC trials have demonstrated safety and efficacy, only a small number of MSC products have reached commercialization, indicating that the therapeutic market for MSCs remains early-stage. Population aging and an increasing prevalence of chronic disease are also driving interest in MSC-based therapies. Furthermore, Google Trend data reveals that MSC searches are more than twice as common as the next most common stem cell type. The demand for both MSCs and MSC-based research products have surged in recent years.

Today in 2021, nearly one-hundred different market competitors are developing various types of MSC-related products/services, therapies, and manufacturing technologies. Within this ever-changing landscape, having a thorough understanding of the competition and their relative strengths and weaknesses is essential. Therefore, this global strategic report details the activities of 98 leading MSC companies. It also presents detailed market size figures for the global MSC market, segmented by geography and business segment, accompanied by five-year forecasts through 2027.

With the competitive nature of this global market, you do not have the time to do the research. Claim this report to become immediately informed, without sacrificing hours of unnecessary research or missing critical opportunities.

The main objectives of this report are to provide the reader with the following details:

  • Market size determination for the global MSC market, segmented by geography and business segment
  • Five-year forecasts for the global MSC market
  • Details of the product candidates being developed by MSC companies
  • MSC market trends, opportunities, risks, and competitive dynamics
  • Major diseases addressed by MSCs in the ongoing clinical trials
  • Cost of manufacturing autologous and allogeneic MSCs
  • Consumption of MSCs for academic research, clinical trials, product development, and exosome production
  • Trend rate data for MSC scientific publications
  • Rates, quantities, geographic locations, and types of MSC clinical trials
  • Types and sources of MSC industry funding
  • Recent business developments related to MSCs
  • MSC-based products with marketing approval and the companies commercializing them
  • Currently marketed MSC-based bone matrices
  • Pricing comparison of MSC-based products with marketing approval
  • Emerging applications for MSCs, including genetic modification, 3D bioprinting, clean meat production and cosmeceuticals
  • Company profiles for 98 MSC market competitors, including their proprietary technologies and products/services under development
  • And so much more

For more comprehensive details about the contents of this report, view the Table of Contents, List of Figures, and List of Tables.

With an online readership of nearly one million viewers per year, BioInformant is a U.S. market research firm with 15 years of experience. As the first and only market research firm to specialize in the stem cell industry, BioInformant research has been cited by the Wall Street Journal, Xconomy, and Vogue Magazine. Founded in 2006 and headquartered in Washington, DC, BioInformant is strategically positioned to be near the National Institutes of Health (NIH), the U.S. FDA, the Maryland Biotech Corridor, and policy makers on Capitol Hill. In addition to leveraging an experienced team of analysts, BioInformant's has unparalleled access to key opinion leaders (KOLs) from across the stem cell sector.

To analyze the rapidly evolving stem cell sector, BioInformant conducts ongoing interviews with prominent executives from across the field. To assess MSC market dynamics, BioInformant interviewed representatives from Cynata Therapeutics (first company to bring an iPSC-derived MSC therapeutic product into a clinical trial), RoosterBio (specializes in manufacturing tens of billions of MSCs in suspension bioreactors), Celularity, Inc. (developing MSC therapeutics from the post-partum human placenta), Pluristem Therapeutics (commercializing placenta-derived mesenchymal-like adherent stromal cells in late-stage clinical trials), BioEden (leading company preserving MSCs derived from dental tissues), Regenexx (world's leading provider of MSC therapies for orthopedic applications), and numerous others. As the first and only market research firm to specialize in the stem cell industry, BioInformant is your trusted leader in stem cell industry data.

EXECUTIVE SUMMARY

Mesenchymal stem cells (MSCs) are multipotent cells that can differentiate into a variety of cell types, including but not limited to osteoblasts, chondrocytes, myocytes, and adipocytes. In addition to secreting factors that can stimulate tissue repair, MSCs can substantially alter their microenvironment, exerting effects that are both anti-inflammatory and anti-fibrotic. MSCs are advantageous over other stem cells types for a variety of reasons, including that they are immuno-privileged, making them an advantageous cell type for allogenic transplantation. MSCs appear to be an exceptionally promising tool for cell therapy, because of their unusual advantages, which include availability, expandability, transplantability, and ethical implications. Interest in therapeutic applications of human MSCs arises from their diverse ability to differentiate into a range of cell types, as well as their ability to migrate to sites of tissue injury/inflammation or tumor growth.

Naturally, a broad range of research products have been developed around MSCs and their differentiated cell types. Growing attention is also being given to manufacturing technologies to support commercial-scale production of MSCs. MSCs are well-suited for use in the exponential growth field of 3D printing, because of their capacity to form structural tissues. Numerous market competitors are exploring commercialization strategies for MSC-derived extracellular vesicles (EVs) and exosomes, because these extracellular "packages" represent a novel strategy for accessing the therapeutic effects of stem cells without the risks of administering whole cells to patients. Finally, gene editing of MSCs for overexpressing antitumor genes or therapeutic factors is broadening their application.

As the most common stem cell type being used within regenerative medicine today, there is huge potential for growth within the MSC market. There are more than one-hundred thousand scientific publications published about MSCs, as well over 1,100 MSC clinical trials underway worldwide. Current "hotspots" for MSC clinical trials include the U.S., E.U., China, Middle East, and South Korea. While many early-stage MSC trials have demonstrated safety and efficacy, only a small number of MSC products have reached commercialization, indicating that the therapeutic market for MSCs remains early-stage. Population aging and an increasing prevalence of chronic disease are also driving interest in MSC-based therapies. Furthermore, Google Trend data reveals that MSC searches are more than twice as common as the next most common stem cell type. The demand for both MSCs and MSC-based research products have surged in recent years.

Today in 2021, nearly one-hundred different market competitors are developing various types of MSC-related products/services, therapies, and manufacturing technologies. Within this ever-changing landscape, having a thorough understanding of the competition and their relative strengths and weaknesses is essential. Therefore, this global strategic report details the activities of 98 leading MSC companies. It also presents detailed market size figures for the global MSC market, segmented by geography and business segment, accompanied by five-year forecasts through 2027.

With the competitive nature of this global market, you do not have the time to do the research. Claim this report to become immediately informed, without sacrificing hours of unnecessary research or missing critical opportunities.

The main objectives of this report are to provide the reader with the following details:

  • Market size determination for the global MSC market, segmented by geography and business segment
  • Five-year forecasts for the global MSC market
  • Details of the product candidates being developed by MSC companies
  • MSC market trends, opportunities, risks, and competitive dynamics
  • Major diseases addressed by MSCs in the ongoing clinical trials
  • Cost of manufacturing autologous and allogeneic MSCs
  • Consumption of MSCs for academic research, clinical trials, product development, and exosome production
  • Trend rate data for MSC scientific publications
  • Rates, quantities, geographic locations, and types of MSC clinical trials
  • Types and sources of MSC industry funding
  • Recent business developments related to MSCs
  • MSC-based products with marketing approval and the companies commercializing them
  • Currently marketed MSC-based bone matrices
  • Pricing comparison of MSC-based products with marketing approval
  • Emerging applications for MSCs, including genetic modification, 3D bioprinting, clean meat production and cosmeceuticals
  • Company profiles for 98 MSC market competitors, including their proprietary technologies and products/services under development
  • And so much more

For more comprehensive details about the contents of this report, view the Table of Contents, List of Figures, and List of Tables.

With an online readership of nearly one million viewers per year, BioInformant is a U.S. market research firm with 15 years of experience. As the first and only market research firm to specialize in the stem cell industry, BioInformant research has been cited by the Wall Street Journal, Xconomy, and Vogue Magazine. Founded in 2006 and headquartered in Washington, DC, BioInformant is strategically positioned to be near the National Institutes of Health (NIH), the U.S. FDA, the Maryland Biotech Corridor, and policy makers on Capitol Hill. In addition to leveraging an experienced team of analysts, BioInformant's has unparalleled access to key opinion leaders (KOLs) from across the stem cell sector.

To analyze the rapidly evolving stem cell sector, BioInformant conducts ongoing interviews with prominent executives from across the field. To assess MSC market dynamics, BioInformant interviewed representatives from Cynata Therapeutics (first company to bring an iPSC-derived MSC therapeutic product into a clinical trial), RoosterBio (specializes in manufacturing tens of billions of MSCs in suspension bioreactors), Celularity, Inc. (developing MSC therapeutics from the post-partum human placenta), Pluristem Therapeutics (commercializing placenta-derived mesenchymal-like adherent stromal cells in late-stage clinical trials), BioEden (leading company preserving MSCs derived from dental tissues), Regenexx (world's leading provider of MSC therapies for orthopedic applications), and numerous others. As the first and only market research firm to specialize in the stem cell industry, BioInformant is your trusted leader in stem cell industry data.

To analyze the rapidly evolving stem cell sector, BioInformant conducts ongoing interviews with prominent executives from across the field. To assess MSC market dynamics, BioInformant interviewed representatives from Cynata Therapeutics (first company to bring an iPSC-derived MSC therapeutic product into a clinical trial), RoosterBio (specializes in manufacturing tens of billions of MSCs in suspension bioreactors), Celularity, Inc. (developing MSC therapeutics from the post-partum human placenta), Pluristem Therapeutics (commercializing placenta-derived mesenchymal-like adherent stromal cells in late-stage clinical trials), BioEden (leading company preserving MSCs derived from dental tissues), Regenexx (world's leading provider of MSC therapies for orthopedic applications), and numerous others. As the first and only market research firm to specialize in the stem cell industry, BioInformant is your trusted leader in stem cell industry data.

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