The World Marrow Donor Association (WMDA) connects researchers, clinicians, and biopharmaceutical companies with a global network of stem cell and cord blood donors.

Our contributions:

• Access to a diverse, ethically sourced donor pool.

• Compliance with international quality, safety, and ethical standards.

• Support for clinical trials and innovative research initiatives.

Substances of human origin (SoHO) can save lives and improve quality of life. They may be used unaltered or processed into innovative therapies such as ATMPs or medical devices.

Key Ethical Risks

1. Violation of fundamental principles
   SoHO are donated altruistically; financial gains must not compromise voluntary donation.

2. Threat to healthcare sustainability
   High commercialisation costs can strain public healthcare systems.

3. Limited patient access
   High prices or supply shortages may restrict availability to those in need.

The goal is to balance innovation, ethics, and equitable access while maintaining trust in donation programs.

The classification of SoHO-based therapies affects safety oversight, commercialisation, and patient access. Ambiguous definitions—such as “substantial manipulation” or “non-homologous use”—can lead to disproportionate requirements, unnecessary costs, and regulatory complexity.

EU & global context:

• The EU new regulations harmonise SoHO oversight and improve collaboration between authorities, industry, and clinicians.

• WHO initiatives support regulatory convergence for cell and gene therapy products worldwide.

1. Preserve non-commercialisation of SoHO

   • Ensure voluntary, unpaid donation.

   • Develop transparent pricing models for proportional profits when appropriate.

2. Transparency in donor consent

   • Inform donors about therapy use, research, and potential commercial applications.

3. Regulatory coordination

   • Multidisciplinary oversight of transplantation, transfusion, ATMPs, and medical devices.

4. Uniform quality and safety standards

   • Apply proportionate, scientifically justified standards regardless of therapy type.

5. Risk-based clinical research regulation

   • Tailor oversight to the innovation level and patient risk.

6. Assess efficacy of SoHO-based therapies

   • Ensure clinical effectiveness and safety before adoption.

7. Foster innovation in public establishments

   • Enable development of high-value therapies while protecting equity and sustainability.

These measures ensure the altruistic donation of SoHO remains protected, while patients benefit from safe, effective, and innovative treatments.

WMDA members follow stringent ethical and medical standards:

• Certified donor registries and cord blood banks

• Regulatory compliance for starting materials

• Preparation suitable for clinical and research use

WMDA members can easily identify through WMDA’s Search & Match Service starting materials for research and clinical applications.