History & timeline.
A clinician-facing account of regenerative therapy: what the published literature reports, and the sourced history of how the field arrived where it stands today. Nothing here is a claim of safety or efficacy for any product.
The Field / Origins
The published history, and what the record shows
A sourced history of the field’s aims and milestones: discoveries and regulatory decisions, from a 1909 hypothesis to the present. It documents events as they occurred and asserts nothing about the safety or effectiveness of any treatment.
What this page is, and is not
This page describes the history of a scientific field and the regulatory determinations made about it by named government agencies. Every entry reports something that happened: a published finding, an early clinical use, a decision by a regulator, a court ruling, or a documented harm. Determinations are attributed to the agency or court that made them and sourced to primary documents. Each entry, including the note beneath it, is drawn from the sources cited on that card. The facts come from those sources; the cautionary notes are our own.
It does not describe, evaluate, endorse, or support any use of any product available through the laboratories we work with. The laboratories represent that those are human cells, tissues, and cellular and tissue-based products intended to be regulated solely under Section 361 of the Public Health Service Act, prepared in facilities registered with, and subject to inspection by, the FDA. Under the FDA’s framework, that classification is made in the first instance by the manufacturer. Each laboratory classifies the products it makes; Meridian Biologics reports that classification as issued. The FDA does not confirm Section 361 status in advance, and such classifications remain subject to FDA review and enforcement. Registration of a facility, however, is not approval of a product: these products are not FDA-approved. An approval granted to another product, by another regulator, in another country, for another condition confers nothing on them, and nothing on this page should be read as suggesting otherwise. No cord-derived or other perinatal-tissue product holds an FDA biologics license for any musculoskeletal, orthopedic, or pain indication (as of October 2026). No product from any laboratory we work with appears anywhere on this timeline.
Entries appear here because they changed the field’s direction — including those that reflect poorly on it. This page is not a catalog of approvals: the FDA maintains the authoritative list of licensed cellular and gene therapy products, and approval of one product, in any country, implies nothing about any other.
The field spans a wide range of maturity: some approaches have decades of clinical use behind them, some are still in early investigation, and some were tried and did not work. The history below is one way to tell those apart. It is not a complete record — the field is far too large for that.
Two lineages
Cells and tissue can come from the patient (autologous) or from a donor (allogeneic). The two paths face different scientific and regulatory obstacles. They are tracked separately below; foundational science belongs to both.
A global history, a US framework
The science has never been confined to one country — key work came from Germany, Russia, Canada, and France. Entries are marked with where they happened. Regulatory entries center on the US framework.
What "approved" means here
"Approved" is a specific legal status granted by a named regulator, and is identified as such wherever it appears. Products regulated under Section 361 do not undergo premarket review, which means approval is not a status available to them: no Section 361 product can appear on this timeline as FDA-approved, because none is ever FDA-approved.
Inclusion is not endorsement
Nothing is listed here because it is recommended, available, or advisable.
The founding idea
Entries in this period run from a 1909 Berlin lecture to experiments reported from Toronto in 1961.
Berlin Hematological Society
Alexander Maximow tells the Berlin Hematological Society on June 1 that every type of blood cell descends from a single common precursor, publishing the argument in Folia Haematologica the same year.
Sources: Maximow A. Folia Haematologica 1909;8:125–134 (English translation: Cell Ther Transplant 2009) · Ramalho-Santos M, Willenbring H. On the origin of the term "stem cell." Cell Stem Cell 2007;1:35–38
Bone marrow
E. Donnall Thomas and colleagues in Cooperstown, New York, infuse donor bone marrow into patients, publishing their first report of human marrow grafting in 1957.
Sources: Thomas ED et al. N Engl J Med 1957;257:491–496 · Thomas ED et al. J Clin Invest 1959;38:1709–1716 · Thomas ED, Nobel Lecture, 1990
The 1961/1963 papers
James Till and Ernest McCulloch, in Toronto, introduce a spleen colony assay that makes blood-forming cells countable. Follow-up experiments two years later show that each colony arises from a single cell able to produce multiple blood lineages — and that those cells self-renew.
Sources: Till JE, McCulloch EA. Radiat Res 1961;14:213–222 · Becker AJ et al. Nature 1963;197:452–454 · Siminovitch L et al. J Cell Comp Physiol 1963;62:327–336 · McCulloch EA, Till JE. Nat Med 2005;11:1026–1028
From laboratory to bedside
Entries in this period cover early sustained clinical use of cell therapy, and the separation of patient-derived and donor-derived approaches into distinct lines of work.
The first successful matched-sibling transplant
Robert Good’s team at the University of Minnesota infuses marrow from a matched sibling into an infant with severe combined immunodeficiency. The patient survives.
Sources: Gatti RA et al. Lancet 1968;2:1366–1369 · Thomas ED, Nobel Lecture, 1990 · In Memoriam: Richard A. Gatti, MD. J Hum Immun 2025;2:e20250225
A second population in marrow
Alexander Friedenstein identifies a non-blood-forming, colony-forming cell in bone marrow capable of generating bone and cartilage. This is the ancestor of what would later be called the mesenchymal stem cell.
Sources: Friedenstein AJ et al. Cell Tissue Kinet 1970;3:393–403 · Friedenstein AJ et al. Transplantation 1968;6:230–247 · Caplan AI. J Orthop Res 1991;9:641–650 · Phinney DG. Bioengineering 2024;11:534
Skin grown from the patient
Cultured epidermal autografts are reported in The Lancet: full-thickness burns covered with sheets grown from the patient’s own cells, expanded in culture before use.
Sources: O’Connor NE et al. Lancet 1981;1:75–78 · Green H. BioEssays 2008;30:897–903 · ter Horst B et al. Adv Drug Deliv Rev 2018;123:18–32
Birth tissue enters the clinic
Eliane Gluckman performs the first umbilical cord blood transplant in Paris — a child with Fanconi anemia receives cells from a sibling’s cord blood.
Sources: Gluckman E et al. N Engl J Med 1989;321:1174–1178 · Gluckman E et al. Br J Haematol 2011;154:441–447 · Kurtzberg J. Stem Cells Transl Med 2017;6:1309–1311
"Mesenchymal stem cells" named
Arnold Caplan gives Friedenstein’s marrow stromal population a name and a research program. The term will later be applied — often loosely — to a wide range of products.
Sources: Caplan AI. Mesenchymal stem cells. J Orthop Res 1991;9:641–650 · Caplan AI. Mesenchymal stem cells: time to change the name! Stem Cells Transl Med 2017;6:1445–1451
The US framework
Entries in this period cover the regulatory framework built in the US to separate minimally manipulated tissue from products requiring premarket authorization.
2005
The HCT/P framework takes shape
The FDA builds 21 CFR Part 1271 in stages: establishment registration and product listing in 2001, followed by donor eligibility and current good tissue practice requirements effective in 2005.
Sources: 66 FR 5447 (Jan. 19, 2001) · 69 FR 29786 (May 25, 2004) · 69 FR 68612 (Nov. 24, 2004) · 21 CFR Part 1271
Oversight and enforcement
Entries in this period cover a published report of patient harm, the end of a federal enforcement-discretion period, court decisions addressing what requires approval, and a summary of where the field stands.
Three patients lose vision at a Florida clinic
The New England Journal of Medicine reports in March that three women in their seventies and eighties, seen for macular degeneration at a Florida clinic in 2015, received injections of autologous adipose-derived cells into both eyes. All three lost most or all remaining vision.
Sources: Kuriyan AE et al. Vision loss after intravitreal injection of autologous "stem cells" for AMD. N Engl J Med 2017;376:1047–1053 · ClinicalTrials.gov NCT02024269 · Marks PW et al. N Engl J Med 2017;376:1007–1009
Enforcement discretion ends
On May 31, 2021, the FDA’s transitional policy for HCT/Ps that did not clearly meet the Section 361 criteria comes to an end.
Sources: FDA guidance, Minimal Manipulation and Homologous Use (Nov. 2017, updated July 2020) · FDA news release, July 20, 2020 (archived) · FDA/CBER Q&A, end of the compliance and enforcement policy
2025
Two circuits reach the same conclusion
In June 2021 the Eleventh Circuit held that a Florida clinic’s adipose stromal vascular fraction product met neither the same-surgical-procedure exception nor the Section 361 criteria, and was therefore a drug requiring approval. In September 2024 the Ninth Circuit reached the same conclusion in a California case, reversing a district court that had ruled the other way. The Supreme Court declined to review that decision on October 14, 2025.
Sources: United States v. US Stem Cell Clinic, LLC, 998 F.3d 1302 (11th Cir. 2021) · United States v. California Stem Cell Treatment Center, No. 22-56014 (9th Cir. 2024) · Sup. Ct. Docket No. 24-1189 · United States v. Carver, 260 U.S. 482, 490 (1923)
A narrow core, and a much larger field around it
A defined set of cell and gene therapies now hold marketing approval. Alongside them sit thousands of registered cell-therapy trials worldwide, and a far larger volume of tissue-based practice operating outside the approval process entirely — some of it regulated under Section 361, some of it the subject of the enforcement actions and litigation described above.
Sources: FDA, Approved Cellular and Gene Therapy Products (accessed October 2026) · Wang M et al. Front Pharmacol 2026;17:1715984 · Turner L. Cell Stem Cell 2021;28:1891–1895
Read this before you use anything on this page
Nothing on this page is a recommendation to treat any patient. It contains no protocol, no indication, no dose, no route, no patient-selection criterion, and no suggestion that any condition described here can be treated with anything the laboratories we work with make available. No entry should be read as guidance, encouragement, or implied support for any clinical use. If any passage here reads to you as pointing toward a use, that reading is not intended and is not correct. Nothing on this page asserts that any therapy described here is safe or effective for any condition. Research findings are reported as published; they are not claims of clinical efficacy.
None of the products made by the laboratories we work with are FDA-approved. Each laboratory represents that its products are human cells, tissues, and cellular and tissue-based products intended to be regulated solely under Section 361 of the Public Health Service Act, and that it prepares them in a facility registered with the FDA — a status that can be checked in the FDA’s public establishment registration database. Under the FDA’s framework, that classification is made in the first instance by the manufacturer. Each laboratory classifies the products it makes; Meridian Biologics reports that classification as issued. The FDA does not confirm Section 361 status in advance, and whether a product meets the criteria in 21 CFR 1271.10 remains subject to FDA review and enforcement at any time. Registration of a facility is not approval of a product: products in that category do not undergo premarket review, and the absence of premarket review is not approval and must not be described or understood as approval. No product from any laboratory we work with appears anywhere on this timeline.
Approvals do not transfer. An approval is granted to one product, made by one manufacturer, for one named indication, by one country’s regulator, on the strength of trial data specific to that product and that indication. It confers nothing on a similar product, a related tissue source, a different use, or a different jurisdiction. Approvals granted outside the United States carry no US regulatory status whatsoever. Most of what is available in practice today has never been through any approval process anywhere — a statement about regulatory status, not about any individual product’s merit.
Clinical, regulatory, and legal judgment remain entirely yours. Nothing here is medical, legal, or regulatory advice, and none of it substitutes for your own review of the primary literature, the current regulations in your jurisdiction, or the counsel of your own attorney. Meridian Biologics does not evaluate protocols, does not advise on whether a use is permissible, and will decline to do so if asked.
Milestone dates, regulatory determinations, and court rulings are drawn from primary sources including the FDA’s list of Approved Cellular and Gene Therapy Products, Federal Register rulemakings, announcements from the EMA, published federal appellate opinions, Karolinska Institutet’s published findings, and the peer-reviewed literature. Where an entry reports a regulator’s determination, that determination belongs to the named agency and not to this company. Last reviewed and updated: October 2026.