As stem cell therapy becomes more mainstream, patients face an increasingly important question: How do you know if the cells you're receiving are safe, viable, and of the highest quality?

The answer lies in understanding laboratory standards—specifically, what AABB accreditation and FDA registration mean for your safety.

The Wild West of Stem Cell Therapy

Not all stem cell providers are created equal. The regenerative medicine field has seen rapid growth, and unfortunately, that growth has included some clinics offering substandard products with little oversight.

Red Flags to Watch For

Be cautious of providers who can't tell you where their cells come from, refuse to discuss laboratory certifications, make claims that sound too good to be true, or offer prices that seem suspiciously low.

This is why understanding laboratory accreditation is essential for any patient considering stem cell therapy.

What is AABB Accreditation?

AABB (formerly known as the American Association of Blood Banks) is an international organization that sets standards for cellular therapy products, including stem cells. AABB accreditation means a laboratory has voluntarily undergone rigorous evaluation and meets the highest standards for:

  • Quality management systems: Comprehensive protocols for every step of cell processing
  • Personnel qualifications: Staff training and competency requirements
  • Equipment and facilities: Proper maintenance and validation of all laboratory equipment
  • Donor screening: Rigorous testing and evaluation of source tissue
  • Processing procedures: Standardized methods for cell isolation and preparation
  • Storage and distribution: Proper handling to maintain cell viability
  • Documentation: Complete traceability from donor to patient

What Does FDA Registration Mean?

The FDA regulates human cells, tissues, and cellular and tissue-based products (HCT/Ps). An FDA-registered laboratory must:

  • Register with the FDA and list their products
  • Follow Current Good Tissue Practice (CGTP) requirements
  • Screen and test donors for communicable diseases
  • Maintain detailed records for traceability
  • Report adverse events

FDA registration provides an additional layer of oversight and accountability.

Why This Matters for Your Treatment

Cell Viability

Stem cells are living cells, and their therapeutic potential depends on them being alive and functional when they reach you. Poor handling, improper storage, or inadequate processing can result in dead or damaged cells that provide no benefit.

Accredited laboratories have validated protocols to ensure cells maintain high viability throughout processing and storage.

Safety and Sterility

Cellular products that aren't properly processed can carry risks of contamination or infection. AABB standards include rigorous sterility testing and environmental controls to minimize these risks.

Consistency

When you receive treatment from cells processed at an accredited lab, you can expect consistent quality from batch to batch. This isn't always the case with unaccredited sources.

Traceability

Accredited laboratories maintain complete documentation from donor to recipient. If any issues arise, there's a clear chain of custody to investigate.

Questions to Ask Your Provider

Before undergoing stem cell therapy, ask:

  • "Is your laboratory AABB accredited?"
  • "Is your lab FDA registered?"
  • "What is the viability of the cells I'll receive?"
  • "How are donors screened?"
  • "What testing is performed on the final product?"
  • "Can you provide documentation of your laboratory's credentials?"

A reputable provider will welcome these questions and provide clear, verifiable answers.

The Regenecell Standard

At Regenecell, we source our umbilical cord-derived mesenchymal stem cells exclusively from an AABB-accredited, FDA-registered laboratory. This means:

  • Every batch undergoes comprehensive testing
  • Cell viability is verified before release
  • Complete traceability from donor to patient
  • Rigorous screening of all donor tissue
  • Validated processing protocols

We believe our patients deserve nothing less than the highest quality cells available.

"When you're putting cells into your body, quality isn't something to compromise on. AABB accreditation and FDA registration aren't just bureaucratic checkboxes—they're your assurance that the product meets the highest standards of safety and quality."