Harvard Medical School Affiliated Research Institute

Harvard Regenerative
Medicine Institute

Advancing the Future of Regenerative Medicine  |  Translating Breakthrough Science into Patient Care

"From Bench to Bedside: Innovating Regenerative Therapies for Global Health"

Harvard-Affiliated
FDA-Compliant
Global Collaborations
Scroll to explore our innovations
Core Services

Comprehensive Regenerative Medicine Solutions

From technology commercialization to clinical-grade testing and world-class literature resources — all under one Harvard-endorsed platform.

Technology Commercialization

Technology Commercialization

Full-chain commercialization services for Harvard regenerative medicine research achievements, following U.S. Office of Technology Licensing (OTL) standards — connecting research, patent, industry, and market.

  • Research Achievement Screening & Evaluation
  • Patent Layout & IP Protection
  • Entrepreneurship Incubation & Financing
  • Industry Cooperation & Technology Licensing
Trusted by 50+ Biotech Startups & Global Pharma Partners
Third-Party Testing

Third-Party Testing

Compliant testing services meeting GLP, ISO 17025, and CLIA standards. Authoritative testing qualifications providing full-process support for biological products, cell therapies, and peptide products.

  • Bioactivity Testing (Hirudin, Nattokinase, Peptides)
  • Safety & Toxicology Evaluation
  • Quality Control & Method Validation
  • Regulatory Compliance Consulting (FDA/EMA/PMDA)
CLIA-Certified | GLP-Compliant | FDA- Recognized Testing Protocols
ISO 17025GLPCLIA
Medical Literature Database

Medical Literature Database

A world-top regenerative medicine literature search and analysis platform endorsed by Harvard, integrating 1M+ high-quality academic resources for researchers, clinicians, and enterprise R&D teams.

  • Full-Field Literature Search (1M+ Publications)
  • Specialized Databases (5 Core Research Directions)
  • Bibliometric Analysis & Trend Reports
  • Research Collaboration Matching & Expert Network
Curated by Harvard Medical School Faculty | Updated Daily
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Harvard HRMI Laboratory

Microscope Observation Scene

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About Us

Advancing Regenerative Medicine Through Innovation

Established 2010Harvard AffiliatedBoston, MA, USA

The Harvard Regenerative Medicine Institute (HRMI) is a world-leading research institute affiliated with Harvard Medical School, dedicated to translating groundbreaking regenerative medicine discoveries into clinical solutions for patients worldwide. Our team of Harvard faculty, researchers, and industry experts bridges the gap between bench science and bedside care, driving innovation in cell therapy, gene editing, tissue engineering, and precision medicine.

"To Cure, To Heal, To Regenerate: Advancing Human Health Through Regenerative Medicine"

500+
Peer-Reviewed
Publications
100+
Active Clinical Trials
200+
Global Collaborations
Our Leadership

World-Class Faculty & Research Leaders

JW

Prof. James Wilson, MD PhD

Institute Director
Harvard Medical School
SC

Prof. Sarah Chen, PhD

Head of Cell Therapy
Stem Cell Biology
MR

Prof. Michael Roberts, MD

Clinical Trials Director
Translational Medicine
AL

Prof. Anna Liu, PhD

Research Lead
Gene Editing & Genomics
Technology Translation

Technology Translation: From Lab to Market

Full-process U.S. technology transfer standards — from preclinical development to regulatory approval and global market entry.

Preclinical Development

Full-process preclinical support complying with FDA IND application standards.

  • In Vitro/In Vivo Efficacy Testing
  • Pharmacology & Toxicology Studies
  • Process Development & Scale-Up
  • CMC Regulatory Support

Clinical Trials

Full-process Phase I–IV clinical trial services, GCP-compliant, Harvard Clinical Center resources.

  • Phase I–IV Trial Design & Execution
  • Harvard Clinical Center Connection
  • Patient Recruitment & Management
  • Data Monitoring & Statistical Analysis

Patent Strategy

Full-life-cycle patent protection services, maximizing IP value, Harvard IP policy compliant.

  • Global Patent Layout (US/EU/CN/JP)
  • Patent Infringement Analysis
  • Technology Licensing Negotiation
  • Harvard IP Policy Compliance

Regulatory Compliance

Full-process consulting for global regenerative medicine regulatory compliance.

  • FDA IND/BLA Submission Support
  • EMA/PMDA Global Regulatory Consulting
  • GMP/GLP/GCP System Implementation
  • Regulatory Audit & Remediation
Clinical Trials

Active & Recruiting Clinical Trials

Relying on Harvard Clinical Center resources, providing full-process Phase I–IV clinical trial services complying with GCP standards.

RECRUITING

Phase II: Hirudin-Based Anticoagulant Therapy in Cardiovascular Disease

Evaluating the efficacy and safety of recombinant hirudin in patients with acute coronary syndrome. Multi-center, randomized, double-blind trial.

Phase: II
Enrollment: 240
Site: MGH Boston
ACTIVE

Phase III: Nattokinase Supplementation in Thrombosis Prevention

Large-scale Phase III trial assessing nattokinase as a prophylactic agent in high-risk thrombosis populations. FDA IND approved.

Phase: III
Enrollment: 580
Site: BWH Boston
COMPLETED

Phase I: Peptide-Based Regenerative Scaffold for Cartilage Repair

First-in-human safety study of a novel peptide scaffold for articular cartilage regeneration. Results published in Nature Medicine.

Phase: I
Enrollment: 48
Site: DFCI Boston
Third-Party Testing

Comprehensive Testing Services

Comprehensive Testing Services

ISO 17025 Certification

Authoritative testing qualifications; legally binding test reports recognized internationally.

GLP Compliance

Strict GLP standards ensuring authenticity, reliability, and traceability of experimental data.

CLIA Certification

Clinical testing services with FDA-recognized results for diagnostic and research applications.

Biologics Potency Testing

Potency testing for cell therapies, protein drugs, peptides, Hirudin, and Nattokinase.

Stability & Impurity Testing

Long-term, accelerated, and stress testing; impurity profiling for heavy metals and microorganisms.

Testing Process

1

Sample Submission

Submit online application, fill in sample information and testing requirements, obtain submission number.

2

Sample Receipt & Logging

Laboratory receives, verifies, and registers samples into the management system for full traceability.

3

Analysis & Testing

Standardized testing using professional instruments; data recorded for accuracy assurance.

4

Quality Review

Professional quality auditors review data and processes; audit opinions issued.

5

Report Delivery

FDA/ISO-compliant test reports delivered via email; online download and query available.

6

Post-Report Support

Result interpretation, compliance suggestions, and re-testing services provided on request.

Medical Literature Database

Harvard-Endorsed Literature & Research Platform

Access 1M+ peer-reviewed publications across all regenerative medicine subdivisions. Curated by Harvard Medical School faculty, updated daily.

Advanced SearchSupports keyword, author, journal, and year filtering

Advanced Search

Precise screening by author, journal, year, research direction, and literature type. Save search conditions for quick repeat queries.

1,000,000+ Publications

Literature Alerts

Customize research directions and keywords. System pushes latest relevant literature daily, weekly, or monthly via email or in-site messages.

Real-Time Push

Research Tools

Bibliometric analysis, citation networks, and trend prediction. Generate literature citation networks and research hotspot trend charts.

Export Analysis Reports

Expert Insights

In-depth interpretations of cutting-edge regenerative medicine research by Harvard Medical School professors and leading global experts.

Harvard Faculty Curated