Donor screening and laboratory quality control
Patients should be able to see what has been tested, which methods were used and what the results show, not rely on verbal assurances.
Certificate of Analysis and laboratory transparency
Every patient receives a Certificate of Analysis (CoA), together with supporting laboratory documentation identifying the specific assays performed, the results obtained and the testing procedures used for the stem cells being administered.
I believe patients should have access to actual laboratory documentation rather than being expected to rely solely on verbal assurances. Transparency means being able to see what has been tested, which methods have been used and what the results demonstrate.
Ask any clinic you are considering for the same documents. Comparing the actual reports, not the marketing, is the best way to judge how cells have been prepared.
Certificate of Analysis
What every patient receives for the cells they are given
Donor screening for spike protein
| Spike antigen ELISA | Donor blood and donor tissue |
|---|---|
| S1 subunit and full-length spike | Both forms tested in the donor |
| Final MSC preparation | Tested again for detectable spike protein |
Laboratory quality control
| Sterility | Validated microbial culture |
|---|---|
| Endotoxins | Recombinant Factor C (rFC) assay |
| Mycoplasma | Real-time PCR (qPCR) |
| Cell viability | Flow cytometry, validated live/dead assay |
Potency and identity
| T-cell suppression | Functional test of immunomodulation |
|---|---|
| Cell surface markers | Confirms MSC characteristics |
With copies of the actual laboratory reports: assay names, results and detection limits.
Donor screening and spike protein testing
The stem cells used for my patients must come from donors who test negative for detectable SARS-CoV-2 spike protein. The screening and testing procedures I require include:
-
Spike antigen ELISA testing
Used to screen for the presence of spike protein.
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S1 protein and full-length spike detection
Donors are specifically tested for both the S1 spike protein subunit and full-length spike protein.
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Donor and tissue screening
Spike protein testing is performed on donor blood and donor tissue. Testing is repeated before stem cell collection and processing.
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Laboratory documentation
Patients receive copies of the actual laboratory reports, including assay names, test results and detection limits.
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Final preparation testing
The final mesenchymal stromal cell (MSC) preparation is also tested to establish whether detectable spike protein is present.
Quality control and potency
These procedures form part of my approach to donor screening, laboratory quality control, cell characterisation and patient safety.
| Test | Method |
|---|---|
| Sterility | Validated microbial culture testing |
| Endotoxins | Recombinant Factor C (rFC) assay |
| Mycoplasma | Real-time polymerase chain reaction (qPCR) |
| Cell viability | Flow cytometry using a validated live/dead assay |
MSC potency and functional testing
I place considerable importance on the biological characteristics and functional properties of the mesenchymal stromal cells being administered. Laboratory assays are used to assess MSC potency and immunomodulatory function. These include:
- Functional T-cell suppression assays
- Standard cell viability assessments
- Cell surface marker testing
Stem cell safety is not optional
Behind every stem cell treatment there should be careful donor selection, a thorough review of the donor's medical history, laboratory testing and strict quality control. As a physician, I believe patients deserve transparency, responsible medical decisions and the highest possible standards of safety. My commitment is simple: quality, safety, science and patient care, because every patient deserves to know what they are receiving and why.
Why I publish these standards
My objective is to maintain a high level of transparency throughout the process, ensuring that patients receive documentation relating to the donor screening, laboratory testing and quality control procedures associated with their treatment.
I would particularly like to see greater collaboration between doctors, independent laboratories and researchers to establish consistent approaches to donor screening, cell characterisation, potency testing and quality assurance. I do not believe these standards should be unique to my practice, and I hope they will inspire wider adoption throughout the stem cell community.
Questions about the testing?
Ask Dr. Celma directly. He will reply to you personally by email.