Tracking regenerative medicine, evidence by evidence.

Our background

DYPHI was founded by internal medicine specialists from Seoul National University and engineers with doctoral training from KAIST.

The company has worked with clinicians, researchers, hospitals, universities, and community health programmes across five continents. Its work has included evidence-based healthcare technology, healthy ageing, frailty, sarcopenia, physical function, rehabilitation, and community health assessment.

This background is directly relevant to regenerative medicine. Many regenerative interventions are discussed in relation to ageing, mobility, osteoarthritis, neurological disease, tissue repair, or functional decline. However, biological plausibility and laboratory findings do not automatically translate into meaningful improvement in patients.

RegenBrief therefore pays particular attention to questions such as:

• What condition was actually studied?
• What cell, tissue, extracellular vesicle, or secretome product was used?
• How was it manufactured and characterised?
• Was the study preclinical, observational, or interventional?
• Was there a control group?
• How many participants were included?
• Were outcomes clinical, imaging-based, biomarker-based, or functional?
• How long were participants followed?
• What adverse events were reported?
• Has the finding been replicated?
• What is the regulatory status in the relevant country?

Why RegenBrief was created

Interest in stem cell and exosome treatment is growing faster than most patients can evaluate the evidence. The same term may refer to very different interventions.

For example, “stem cell therapy” may describe:

• autologous or allogeneic cells;
• bone marrow, adipose, umbilical cord, or other sources;
• minimally manipulated or cultured products;
• local or systemic administration;
• a clinical trial;
• an approved product;
• a hospital-based procedure;
• or a commercial intervention with limited published evidence.

Likewise, “exosome treatment” may refer to products with different cell sources, isolation methods, purity, dose, formulation, storage, and quality-control standards.

Without this detail, two treatments with similar names may not be scientifically or clinically comparable. RegenBrief was created to make these differences visible.

What we cover

Research Briefs

Research Briefs explain important papers, reviews, and emerging topics in plain language. Each brief should identify:

• the research question;
• intervention and comparator;
• study population;
• principal findings;
• evidence limitations;
• safety information;
• stage of development; and
• what the findings may and may not mean for current clinical practice.

Clinical Archive

The Clinical Archive organises clinical trials and selected clinical applications by:

• indication;
• cell or product type;
• administration route;
• study phase;
• recruitment status;
• sponsor;
• country;
• outcomes; and
• available publication or registry information.

A registered trial is evidence that a study has been planned or initiated. It is not evidence that the intervention is effective.

Evidence Notes and Statistics

We provide descriptive analyses of clinical research, regulation, reimbursement, and national activity where reliable public data are available. These analyses should distinguish:

• approved products;
• authorised clinical research;
• compassionate or special-access pathways;
• hospital procedures;
• commercial services; and
• interventions that remain investigational.

Functional longevity

RegenBrief uses functional longevity to describe the maintenance of physical independence, mobility, cognitive function, and quality of life for as long as possible. Relevant outcomes may include:

• gait speed;
• muscle strength;
• balance;
• physical performance;
• activities of daily living;
• cognition;
• symptoms;
• participation; and
• quality of life.

A change in a laboratory marker is not automatically equivalent to a meaningful functional benefit.

How we read the strength of evidence

Different study designs support different levels of confidence. We identify the study type on every entry so readers can see where a finding sits.

1. PreclinicalLaboratory and animal studies exploring mechanism and feasibility. Not evidence of clinical benefit in people.
2. Case report / case seriesObservations from one or a few patients, without a comparison group.
3. Observational clinical studyPatients followed without randomised assignment; associations may be confounded.
4. Early-phase interventional trialFirst-in-human or small trials focused on safety and dose, not proof of efficacy.
5. Controlled clinical trialComparison against a control group, ideally randomised, testing whether an effect exists.
6. Confirmatory trialLarger, pre-specified trials designed to confirm efficacy and safety for a defined indication.
7. Systematic synthesis / guidelineSystematic reviews, meta-analyses, and guidelines that integrate the full body of evidence.

This is not an absolute universal hierarchy. Study quality, relevance, consistency, and risk of bias also affect interpretation.

Registered, authorised, available, effective — four different questions

These terms are often used interchangeably, but each answers a different question. A treatment can satisfy the first three and still lack the fourth.

Our editorial principles

Evidence level must be visible

Cell experiments, animal studies, case reports, uncontrolled studies, randomised trials, and systematic reviews do not provide the same level of evidence. The study type should be clearly identified.

Registered does not mean proven

Clinical-trial registration, ethics approval, or regulatory permission does not demonstrate that a treatment is effective.

Biological plausibility is not clinical efficacy

A mechanism may be scientifically interesting without producing a clinically important benefit.

Product identity matters

Cell source, donor relationship, culture method, passage number, dose, viability, formulation, storage, route, and quality control may affect interpretation. The generic label “MSC” or “exosome” is often insufficient.

Safety requires active reporting

The absence of a reported serious adverse event in a small or short study does not establish long-term safety.

Outcomes should matter to patients

Biomarkers and imaging can be informative, but improvements in symptoms, function, independence, and quality of life are often more meaningful.

Uncertainty should not be hidden

When evidence is preliminary, inconsistent, indirect, or commercially influenced, the limitation should be stated near the conclusion.

Regulation varies by country

A treatment allowed under one country's framework may be investigational, restricted, or prohibited elsewhere. Regulatory status can also change and must be dated.

Commercial availability is not proof

A service being sold to patients does not establish effectiveness, superiority, or appropriate manufacturing quality.

How we prepare content

Where possible, RegenBrief prioritises primary and authoritative sources, including:

• peer-reviewed clinical studies;
• systematic reviews and meta-analyses;
• clinical-trial registries;
• regulatory agencies;
• government health authorities;
• professional guidelines;
• official product information; and
• transparent institutional reports.

Each article should include enough source information for readers to locate the underlying evidence. When a statement is based on inference rather than direct evidence, that distinction should be visible.

Conflicts of interest, sponsor involvement, small sample size, short follow-up, lack of controls, selective populations, and surrogate outcomes should be reported when relevant.

Relationship with clinical services

RegenBrief is primarily an evidence and information platform. Where a reader requests information about a clinical service, RegenBrief may help clarify:

• whether the intervention is established or investigational;
• what evidence exists for the stated indication;
• which questions should be asked about the product and manufacturing process;
• what regulatory framework may apply;
• which records may be needed for a professional consultation; and
• which risks and follow-up requirements should be discussed.

RegenBrief does not independently diagnose a condition, prescribe a regenerative intervention, determine eligibility, or guarantee access to a clinical programme. Any clinical decision must be made by appropriately licensed healthcare professionals after an individual assessment.

Part of the DYPHI health-information network

DYPHI operates and supports specialised health-information services that share the principles of evidence, transparency, appropriate professional consultation, and continuity of care.

DYPHI Health Information Network

Corrections, updates, and transparency

Regenerative-medicine evidence and regulation change rapidly. Articles should display their publication date and, where relevant, the date of the most recent substantive review.

Readers, researchers, and clinicians may contact RegenBrief to report:

• factual errors;
• missing primary sources;
• changed trial status;
• regulatory updates;
• corrected or retracted publications; or
• relevant conflicts of interest.

Substantive corrections should be recorded transparently.

Important information

RegenBrief and DYPHI are not hospitals, clinics, or medical practices.

The materials on this website are provided for academic, educational, and general information purposes. They do not constitute medical advice, diagnosis, prescription, treatment recommendation, or a guarantee of benefit.

Inclusion in the Clinical Archive does not represent endorsement. A registered, authorised, or commercially available intervention may still lack adequate evidence of effectiveness or long-term safety.

Individual treatment decisions must be made with qualified healthcare professionals after a review of the patient's condition, available alternatives, regulatory context, potential risks, and follow-up requirements.