Evidence review · Regenerative medicine

What does one million MSCs per kilogram mean?

A commonly used clinical-trial reference can help frame a dose conversation, but it is not a universal optimum or safety ceiling.

Evidence positionClinical-trial dosing contextPrimary sourceGalderisi, Peluso & Di Bernardo, 2022

The paper behind this review

Clinical Trials Based on Mesenchymal Stromal Cells are Exponentially Increasing

Published in 2022 by Galderisi, Peluso and Di Bernardo, this review surveyed the rapidly expanding landscape of clinical trials using mesenchymal stromal cells. It describes how cell sources, indications, routes and doses differ across studies. We use it to place the frequently encountered one-million-cells-per-kilogram figure in context - not to claim that this quantity is universally optimal.

What was studied?

The research question and design

This review examined hundreds of published clinical trials using mesenchymal stromal cells across different diseases, cell sources, routes and dosing approaches. Doses around one million cells per kilogram appear in human studies, alongside both lower and higher quantities.

What researchers found

The useful signal

The literature shows that one million cells per kilogram is a recognizable and frequently used clinical reference. It does not show that one dose is optimal for every person, objective, product or route, and increasing cell quantity does not reliably produce a proportionally better result.

What this does not prove

Limitations that change the interpretation

  • The reviewed trials covered many different medical conditions rather than healthy-aging programmes.
  • Cell source, manufacturing, viability, route and repeat dosing varied substantially.
  • A commonly studied dose is not the same as a proven optimal dose.
  • The review does not establish a universal maximum safe dose or a longevity benefit in healthy adults.

What this means for a consumer

Use the evidence for a better question - not a guarantee.

Use one million cells per kilogram as a point of reference for a physician-led conversation, not as a target to reach automatically. Ask why the proposed quantity fits your health context, objective, cell preparation and route - and what evidence supports choosing more.

Hallmarks connection

Biological pathways discussed

Chronic inflammationIntercellular communicationStem-cell exhaustion

A connection to a hallmark does not demonstrate that the hallmark has been reversed or that aging has slowed.

Continue from evidence to the specific option.

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