Cryopreserved Stem Cell Courier: Cord Blood & HSC Transport
Stem Cell Transport Overview
- Sample Types: Cord blood, HSC, bone marrow
- Temperature: -196°C for cryopreserved samples
- Regulations: FDA, FACT accreditation required
- Chain of Custody: Medical-grade tracking mandatory
- Success Rate: 99.9% with specialized protocols
Stem Cell Transport vs. Embryo Transport
While similar in temperature requirements, stem cell transport has additional regulatory oversight:
Key Differences:
- FDA Regulations: Stem cells regulated as HCT/Ps (Human Cells, Tissues, and Cellular and Tissue-Based Products)
- FACT Accreditation: Many receiving facilities require FACT-accredited transport
- Donor vs. Autologous: Different documentation for donor stem cells
- Therapeutic Use: Often time-sensitive for transplant procedures
Transport Protocol
Cord Blood Transport
- Collection: At birth, processed within 24-48 hours
- Storage: Long-term at cord blood bank
- Transport: From bank to transplant center when needed
- Timeline: Urgent - often for life-threatening conditions
HSC/Bone Marrow Transport
- Source: Donor or autologous collection
- Processing: Fresh (refrigerated) or frozen
- Timeline: Transplant scheduling coordinated
- Backup Samples: Often split shipments for safety
Regulatory Requirements
FDA Requirements:
- Courier must be registered with FDA
- Compliance with 21 CFR Part 1271
- Donor eligibility documentation
- Adverse event reporting protocols
FACT Accreditation:
- Required by many transplant centers
- Specific courier qualifications
- Quality management system
- Regular audits and inspections
Related Resources
Ayo Gbenga
Chief Compliance Officer
With over 15 years of experience in medical logistics and regulatory compliance, Ayo Gbenga leads our commitment to maintaining the highest standards in biological material transport.
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