Regulatory framework · Clinical safety · Quality standards

Safety, science,
and full transparency.

"Your body has never rejected itself. It won't start now."

Regenerys Self® operates under HTA licence, MHRA regulation, and the FDA's autologous framework. Every dose is individually viability and sterility certified. Available exclusively from approved surgeons and specialists.

Starting with the most important question

Is Regenerys Self® safe?

Yes — and here is exactly why, with no ambiguity. The answer begins with the most honest safety statement in aesthetic medicine: your body has never rejected itself. It won't start now.

"Your body has never rejected itself. It won't start now. Regenerys Self®."

Autologous tissue — your own cells returned to your own body — generates no immune response because there is no foreign antigen to respond to. No granuloma. No allergy. No rejection. These risks are categorically absent — not minimised, absent. They simply do not exist for autologous tissue. This is immunology, not marketing.

This page explains the regulatory framework precisely, because patients deserve to understand it rather than simply be reassured.

T&CT regulatory credentials

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HTA Licensed

Human Tissue Authority — UK statutory regulator for human tissue storage

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MHRA Regulated

Medicines and Healthcare products Regulatory Agency

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GMP-Compliant Facilities

Sheffield (UK/EU/Middle East) and Dallas, Texas (USA)

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FDA Compliant

Autologous HCT/P framework — fully notified, transparent and compliant

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Approved surgeons only

Exclusively from qualified plastic surgeons and advanced filler specialists

Regulatory framework

Understanding the regulations
that govern your treatment.

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United Kingdom — Human Tissue Authority

Sheffield facility · UK, EU & Middle Eastern patients

The HTA is the independent statutory body established under the Human Tissue Act 2004. T&CT holds an HTA licence for its Sheffield GMP facility. Autologous tissue sits in the lowest-risk category within the HTA framework — no communicable disease transmission risk, lighter consent requirements than allogeneic products, rigorous quality and traceability standards throughout.

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United States — FDA Compliant Autologous Framework

Dallas facility · US patients

T&CT's US programme qualifies for the FDA's simplified autologous framework when it meets four criteria — all of which T&CT's processing fully satisfies:

Minimally manipulated

Processing does not alter relevant biological characteristics

Homologous use

Soft tissue into soft tissue for volume restoration

Autologous

Donor and recipient are the same person — Self

Not combined with a drug

No foreign biological material added to Self

Under this framework, no pre-market approval, clinical trial, or FDA submission is required. US patients' samples are processed and stored at T&CT's Dallas facility. T&CT does however notify the FDA and is fully transparent to all FDA requests and compliant with all guidances — we are the new gold standard in autologous tissue management.

Every dose certified

Quality control on
every single dose.

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85–95% viability. Fillers: 0%.

Every batch undergoes post-thaw viability testing. 85–95% living cells — vs 25–30% industry standard and 0% for every synthetic or cadaveric product. A viability certificate accompanies every dose.

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Sterility certificate per dose

GMP processing environment. Full chain-of-custody documentation from harvest through dispatch. Every dose individually certified before release.

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Full HTA traceability

HTA-mandated donor-to-use traceability throughout the storage life of your sample. A quality standard no filler manufacturer, no cadaveric product, and no same-day fat transfer can claim.

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Cryogenic banking

-196°C liquid nitrogen vapour phase. Continuous temperature monitoring. Annual independent audits. Dallas (US) and Sheffield (UK/EU/Middle East).

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Proprietary cryopreservation

Naturally occurring, non-toxic compound. No post-thaw wash step required. No prohibited substances. The safety profile is unambiguous: it is yours, preserved to the highest clinical standard available.

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Approved practitioners only

Available exclusively from approved plastic surgeons and advanced filler specialists — not injectables clinics, medspas, or non-surgical practitioners. Quality is guaranteed by clinical skill, not just laboratory process.

Safety, science,and full transparency.