Source desk
Sources we read from.
A source map for a fragmented field — what each regulator, registry, journal, and guideline can and cannot answer for a patient researching regenerative medicine.
Sources checked · 2026-05-14
Information on regenerative medicine is unusually fragmented. There is no single public source that gives a patient a clean view of stem-cell and regenerative-medicine options across regulatory status, clinic quality, evidence level, cost, and medical-tourism logistics. CellDecide exists in that gap — not to invent a new authority, but to stitch the existing ones together without pretending they say more than they do.
The gap is not that there are no sources. The gap is that the sources answer different questions, in different countries, in different vocabularies. CellDecide exists to put those answers on the same page.
This page is the source map behind that work. Every source listed below is paired with the specific question it answers on CellDecide — and, where it matters, the question it does not. Inclusion is not endorsement of any treatment, any clinic, or any jurisdiction.
The categories below are: U.S. and international regulators and ministries, scientific society guidance, systematic reviews and primary literature, specialty-society statements, academic medical-center explainers, trial registries, and provider documents. We close with the translation standard for non-English sources, how a citation appears on a treatment page, and how to flag a source we got wrong.
What each source can — and cannot — answer
No single source on this page answers every question a patient is asking. We use each one for the question it actually answers, and we name what it does not.
- FDA pages answer U.S. regulatory questions — what is approved in the United States, what is under enforcement, what carries which label. They do not answer questions about global access or whether a treatment is available abroad.
- Local regulators and ministries (PMDA, MHLW, MFDS, NMPA, Thai FDA, COFEPRIS, MINSA, EMA, and others) answer local-permission questions — what is authorized, conditionally approved, or running under hospital exemption in a given jurisdiction. They do not answer the broader evidence question of whether the intervention has shown benefit for a specific condition elsewhere.
- Trial registries (ClinicalTrials.gov, WHO ICTRP, EU CTR, jRCT, ChiCTR) answer is a study registered? — and at what phase, with what sponsor, recruiting where. They do not answer does it work? That is what the trial is being run to find out.
- Clinic, hospital, and manufacturer pages answer what does this provider claim? — pricing, protocol, consent language, accreditation, product description. They do not answer is the claim clinically proven? When a provider claim conflicts with a regulator or study source, the page on CellDecide names the conflict and cites both.
- Scientific papers and systematic reviews (PubMed Central, Cochrane Library, peer-reviewed journals) answer narrow study questions — usually one indication, one protocol, one population. They rarely answer the whole-category question and should not be cited as if they do.
- Patient testimonials can reveal questions patients ask, experiences they report, and cost/friction patterns worth investigating. They are not clinical evidence, and we do not use them as such.
Where sources conflict, higher-authority sources (regulators, systematic reviews) take precedence over lower-authority ones (clinic pages, single studies). Where two high-authority sources disagree — for example, a U.S. FDA position vs. a Japanese PMDA conditional approval for the same cellular product — the page names the disagreement instead of resolving it silently.
Tier 1 · Regulatory and official sources
National regulators, health ministries, and supranational bodies that authorize, restrict, or warn about cellular and regenerative products. Each source is listed with the specific question it answers — not as a blanket statement that the regulator endorses stem-cell therapy.
A · United States
FDA Consumer Alert on Regenerative Medicine Products
U.S. Food & Drug Administration — Used to check FDA approval status, the agency's standing position on direct-to-consumer stem-cell marketing, and the boundary between approved cellular therapies and unapproved offerings in the U.S.
https://www.fda.gov/consumers/consumer-updates/fda-warns-about-stem-cell-therapies
FDA Patient Information on Regenerative Medicine Therapies
U.S. Food & Drug Administration — Used to check what FDA's Regenerative Medicine Advanced Therapy (RMAT) designation does and does not signal, and to anchor plain-language framing of FDA pathway status for U.S. readers.
FDA Warning Letter Database
U.S. Food & Drug Administration — Used to verify specific, named, dated FDA enforcement actions against U.S. clinics or product manufacturers. Cited only when we can name the addressee and the letter date.
NIH Stem Cell Information
U.S. National Institutes of Health — Used to check federally-published scientific reference material on what stem cells are, what they do, and which research areas receive federal funding under U.S. oversight.
Centers for Medicare & Medicaid Services
U.S. Department of Health & Human Services — Used to check Medicare and Medicaid coverage status, national coverage determinations, and reimbursement context for U.S. patients considering whether a procedure may be covered.
B · International regulators and ministries
Listed below in alphabetical-by-country order. Inclusion on this list does notmean the listed body has approved stem-cell or regenerative therapies broadly — it means we read the body's official sources when a page on CellDecide covers care in that country.
Pharmaceuticals and Medical Devices Agency (PMDA)
Government of Japan — Used to verify Japanese regulatory pathways, product authorization status (including the conditional / time-limited approval route for regenerative-medical products), and official safety notices when relevant to a specific therapy offered in Japan. Original-language pages may require translation review.
Ministry of Health, Labour and Welfare (MHLW)
Government of Japan — Used to check Japan's regulatory framework for regenerative medicine, including the Act on the Safety of Regenerative Medicine and ministry-level policy and notices. Original-language pages may require translation review.
Ministry of Food and Drug Safety (MFDS)
Republic of Korea — Used to verify South Korean regulatory pathways and biopharmaceutical review status for cellular therapy products. Original-language pages may require translation review.
Thai FDA (Food and Drug Administration)
Ministry of Public Health, Kingdom of Thailand — Used to check Thai product authorization status, drug-and-biologic licensing, and official notices on cellular products marketed in Thailand. Original-language pages may require translation review.
Ministry of Public Health (MoPH)
Kingdom of Thailand — Used to check Thai national health-policy notices, hospital licensing context, and ministry-level documentation when a treatment page covers care offered in Thailand. Original-language pages may require translation review.
Medical Council of Thailand
Medical Council of Thailand — Used to verify Thai physician licensure and registered specialty when a clinic page names a specific treating physician. Cited only when we can match the licensed name on the register.
National Medical Products Administration (NMPA)
People's Republic of China — Used to check Chinese product registration, approval status, and the regulatory boundary between commercial registration and hospital-exception clinical use. Original-language pages may require translation review.
National Health Commission (NHC)
People's Republic of China — Used to check Chinese national health-policy notices and ministry-level regulation of clinical practice for cellular and gene therapy products. Original-language pages may require translation review.
Federal Commission for the Protection against Sanitary Risk (COFEPRIS)
Government of Mexico — Used to check Mexican regulatory authorization status for cellular therapy products and the boundary between commercial approval and clinical-research use. Original-language pages may require translation review.
Ministry of Health (MINSA)
Republic of Panama — Used to check Panamanian regulatory and health-policy notices when a treatment page covers care offered in Panama. Original-language pages may require translation review.
European Medicines Agency (EMA)
European Union — Used to check EU-wide centralized marketing authorization for advanced-therapy medicinal products (ATMPs), including cell, gene, and tissue-engineered therapies, and EMA safety communications.
Tier 2 · Scientific consensus and professional guidance
The international scientific-society layer, systematic reviews, peer-reviewed literature, specialty-society guidance, and academic-medical-center patient explainers. Tier 2 sources confirm, elaborate on, or sit one step downstream from Tier 1 regulatory authority.
A · International scientific society guidance
ISSCR Guidelines for Stem Cell Research and Clinical Translation
International Society for Stem Cell Research — Used as the international scientific-consensus reference for what counts as legitimate stem-cell research vs. direct-to-consumer marketing. Cited when describing the line between investigational and commercial offerings.
ISSCR — Standards for Stem Cell Clinical Translation
International Society for Stem Cell Research — Used to cite the clinical-translation chapter of ISSCR's framework — what an evidence-based translation pathway looks like, and what it does not.
ISSCR — A Closer Look at Stem Cells (patient handbook)
International Society for Stem Cell Research — Used as the ISSCR-curated patient-facing reference on what stem cells are, what current evidence supports, and how to evaluate direct-to-consumer claims — including the difference between marker-level signals and patient-felt clinical outcomes.
B · Systematic reviews and primary literature
Cochrane Library
Cochrane Collaboration — Used as the gold-standard aggregator of systematic reviews and meta-analyses of randomized trials, when a Cochrane review exists for a specific intervention / indication pair. Certainty grading is reported with the citation.
PubMed Central (PMC)
U.S. National Library of Medicine — Used as the open-access archive of biomedical and life-sciences journal literature. Per-study citations link to the PMC record where available; specific journals we read regularly include Human Reproduction (Oxford), BMC, and Frontiers, evaluated per article — not blanket-trusted by venue.
C · Specialty-society guidance
Cited when relevant to a specific indication or procedure — for example, AAOS for orthopedic biologics, ASGCT for cell and gene therapy policy. We read society statements as consensus signals, not as standalone evidence of efficacy.
American Academy of Orthopaedic Surgeons (AAOS) — OrthoGuidelines
American Academy of Orthopaedic Surgeons — Used to check AAOS evidence-based clinical practice guidelines on orthopedic indications where biologics (PRP, BMAC, MSC injections) are marketed against the standard of care.
American Society of Gene and Cell Therapy (ASGCT)
American Society of Gene and Cell Therapy — Used to check society-level statements and educational materials on cellular and gene therapy, including patient-facing explainers for approved therapies and policy commentary.
International Federation for Adipose Therapeutics and Science (IFATS)
International Federation for Adipose Therapeutics and Science — Used to check the scientific society reference point for adipose-derived cellular therapies — guidance on processing, terminology, and the line between research-grade evidence and clinic marketing.
European Society for Blood and Marrow Transplantation (EBMT) — Autoimmune Diseases Working Party and published recommendations
European Society for Blood and Marrow Transplantation — Used to check the transplant-society reference point for autologous hematopoietic stem cell transplantation (HSCT) in severe autoimmune disease — indications, severity groups, procedural context, and procedure-related risk profile. The Autoimmune Diseases Working Party page is the entry point; the substantive content lives in EBMT's periodically updated recommendations on autoimmune HSCT (published in Bone Marrow Transplantation), which name the conditions and severity groups EBMT considers reasonable use cases — most established for severe relapsing multiple sclerosis and severe diffuse systemic sclerosis, with smaller bodies of work in Crohn's disease, systemic lupus erythematosus, and other immune-mediated conditions. Cited as a scoped transplant-society reference, not a universal endorsement of HSCT for autoimmune disease as a category.
International Society for Cell & Gene Therapy (ISCT)
International Society for Cell & Gene Therapy — Used as the international society reference point for cell-therapy manufacturing, quality, and terminology — including the foundational consensus statements on mesenchymal stromal cell identification, potency, and the distinction between cell-type name and defined cell product. Cited when a page rests on a manufacturing or terminology distinction, never as evidence that any commercial MSC product meets the standards ISCT is trying to codify.
Alliance for Regenerative Medicine (ARM) — sector reports
Alliance for Regenerative Medicine — Used as industry-context background on the regenerative-medicine pipeline — how many programs are in development, where capital is moving, which areas are accelerating. Cited as sector context only; not used as evidence of safety, efficacy, or appropriateness of any specific therapy. ARM is an industry organization, not a regulator.
D · Academic medical-center explainers
Used as plain-language references when describing what a cell type is, what a procedure involves, or what is considered standard care. Not treated as primary regulatory authority, and not substituted for Tier 1 sources on questions of approval status.
Cleveland Clinic — Stem Cell Therapy Overview
Cleveland Clinic — Used as a plain-language authority explainer for what stem-cell therapy is and what is currently considered standard vs. investigational. Confirmation source, not primary regulatory authority.
https://my.clevelandclinic.org/health/treatments/17572-stem-cell-therapy
Mayo Clinic — Stem Cells: What They Are and What They Do
Mayo Clinic — Used as a Tier 2 explainer on stem-cell types, sources, and current clinical applications. Confirmation source, not primary regulatory authority.
https://www.mayoclinic.org/tests-procedures/bone-marrow-transplant/in-depth/stem-cells/art-20048117
Harvard Stem Cell Institute — FAQ
Harvard Stem Cell Institute — Used as an academic-medical-center patient-facing reference for common patient questions on stem-cell research and clinical translation.
Kyoto University CiRA — Center for iPS Cell Research and Application
Kyoto University — Used as the academic-research reference point for induced pluripotent stem cell (iPSC) science and translation, anchored in Shinya Yamanaka's foundational work. Cited when a page discusses iPSC platforms or specific Kyoto-led translational programs (for example, dopaminergic-neuron work in Parkinson's disease). Reference for what is being researched, not endorsement of any clinic offering using iPSC vocabulary.
Stanford Institute for Stem Cell Biology and Regenerative Medicine
Stanford University School of Medicine — Used as a U.S. academic-research reference point spanning stem-cell biology, disease modeling, and clinical translation. Cited when a page discusses the bench-to-bedside arc for a defined indication, not as proof that any single program has reached routine clinical use.
Tier 3 · Clinical-trial registries
What a registry listing means
A trial registry listing means a trial is registered. It is not proof that the intervention works, that it is safe, or that it is approved anywhere. Trials are run precisely because those questions are not yet settled.
ClinicalTrials.gov
U.S. National Library of Medicine — Used to confirm that a clinical trial exists, its registration status, study phase, recruitment status, sponsors, and reported results. A registry listing means the trial is registered — nothing about safety, efficacy, or approval.
WHO International Clinical Trials Registry Platform (ICTRP)
World Health Organization — Used as the international meta-registry that aggregates national trial registries. Helpful when a trial is registered outside the U.S. and may not appear on ClinicalTrials.gov.
EU Clinical Trials Register
European Medicines Agency — Used to verify trials conducted under the EU Clinical Trials Regulation, including ATMP (advanced-therapy medicinal product) trials for cell, gene, and tissue-engineered therapies.
Japan Registry of Clinical Trials (jRCT)
Japan National Institute of Public Health — Used to verify Japanese clinical trial registrations, including trials run under the Act on the Safety of Regenerative Medicine. Some entries may require translation review.
Chinese Clinical Trial Registry (ChiCTR)
World Health Organization ICTRP Primary Registry — Used to verify Chinese clinical trial registrations. ChiCTR is a WHO ICTRP primary registry; entries may require translation review against the original-language record.
Tier 4 · Clinic, hospital, and manufacturer documents
Provider-published material — clinic websites, hospital protocols, consent documents, manufacturer product sheets, accreditation directories. Used to verify what a provider claims: pricing, protocol language, consent language, credentials, accreditation, product description. Not treated as proof of clinical benefit unless the underlying claim is independently supported by a Tier 1, 2, or 3 source.
When clinic or manufacturer claims conflict with regulator or study sources, the page on CellDecide states the conflict and cites both sides. We do not silently flatten the difference.
JCI Accredited Organizations Directory
Joint Commission International — Used to verify whether a hospital or healthcare organization holds Joint Commission International accreditation. Accreditation is institutional, not procedure-specific — it does not by itself authorize any regenerative protocol.
https://www.jointcommissioninternational.org/who-we-are/accredited-organizations/
Medical-tourism reference sources
Various (named per page) — Umbrella category for medical-tourism context: JCI accreditation, national hospital-licensing registries, WHO International Travel and Health, and country-specific health-ministry tourism portals. Used to verify destination-level claims about accreditation, licensure, and medical-travel infrastructure — never to certify a specific treatment.
When a source is not in English
A globally aware site reads primary sources in the languages they were published in. Many of the international regulators and ministries on this page maintain official English portals, but the most current and most specific documents — ministry notices, conditional-approval letters, hospital licensing entries, individual trial registrations — are often only available in the original language. The translation standard below is how we handle that without overstating what a translated source proves.
- Official English versions, when they exist.For each international source above, we prefer the regulator's own English-language page or document over any third-party translation. The original-language link is also preserved on the page citing it, when feasible.
- Machine translation as a first pass, not as the citation. If no official English version exists, we may use machine translation to read the document, but the verified citation checks specific terms against the original language and names that translation was used.
- Preserve original names, dates, and approval terms. Regulator names, product names, approval terminology, and dates are preserved in the original where possible (e.g., Japanese 条件付承認 alongside “conditional approval”). Flattening loses regulatory meaning.
- Do not rely on translated snippets alone for high-stakes claims. FDA-status claims, approval-status claims, and safety signals are not cited from a machine-translated paragraph in isolation. We get to a human-reviewed source — official English, peer-reviewed translation, or a credentialed bilingual reviewer — before stating those.
- Name when translation was used. If a citation depends on a translated source, the footnote on the treatment page says so, in plain language.
- When in doubt, say so. If a translation is uncertain or a regulatory term has no clean English equivalent, we say so on the page rather than smoothing it over.
Terms we never flatten
Regulatory categories carry specific meaning in each jurisdiction and frequently do not translate one-to-one. The following terms are preserved in the original language alongside an English description, never substituted with a near-synonym:
- approved vs. conditionally approved vs. time-limited approval
- authorized vs. registered vs. licensed
- hospital exemption / clinical-use pathway / compassionate use
- investigational vs. experimental
- cell-processing and manufacturing terms — minimally manipulated, substantially manipulated, autologous, allogeneic — each of which has a regulator-specific classification effect.
How a citation appears on a treatment page
Each treatment, destination, or clinic page that depends on a source shows the source explicitly. A reader should be able to open the footnote, read the source, and verify the claim against it without leaving the trail.
- What the source supports.The footnote names the specific claim the source backs — not a vague “see source for more.”
- Date checked. Each footnote carries a verification date. Regulatory pages move; the date is the last time we confirmed the linked source matches the claim.
- Publisher. Named, not implied.
- Source type. Whether the citation is a regulator, a registry, a peer-reviewed study, a society guideline, or a provider document — so the reader can weight it accordingly.
- Translation status. If the source is not in English, the footnote states whether the citation was read in the original language, in an official English translation, or via machine translation reviewed against the original.
Source freshness
Tier 1 regulatory sources change. Trials open and close. Conditional approvals in one jurisdiction become full approvals — or get withdrawn. Cochrane reviews get updated. We re-verify cited sources on a quarterly minimum cadence; after any major regulatory action (an FDA enforcement announcement, an ISSCR guideline revision, a major PMDA or EMA decision, a large trial readout), we re-verify the affected pages immediately. Each footnote on a treatment page carries its own verification date.
Corrections and source challenges
If a source link is wrong, outdated, mistranslated, or does not support the page claim it sits next to — tell us. We treat substantiated source corrections as priority work and aim to address them within 48 hours of receipt. Please include the page URL, the specific sentence, and (if you can) the source you believe contradicts it.
How to report
Email admin@celldecide.com, or use the form at /contact. Native-language readers of any of the international regulators on this page are particularly welcome to flag translation errors.
Related
- Methodology — the worldview behind the source tiers, including the evidence ladder and the eight dimensions we score separately.
- About — who runs the site, and the global, evidence-disciplined posture.
- Medical-review policy — what review happens before a page is published, and the current state of clinical review.
- Disclosures — affiliate, advertising, and editorial-independence statements.
- How CellDecide weighs evidence — a plain-English reading guide to lab studies, early human trials, controlled trials, and approvals.
- Questions to ask a stem-cell clinic — the per-clinic question checklist.
- Stem-cell clinic red flags — the marketing patterns we treat as warning signs.