ReoCell is a cell technology center in Kyiv. We cover the full regenerative medicine cycle: we manufacture cell-based products in our biotechnology laboratory and use them to treat patients at ReoCell Clinic. Our biobank and clinic hold a license from the Ministry of Health of Ukraine and are certified to the international quality standard ISO 9001:2015.
In this article, we look at how regenerative medicine has developed worldwide and in Ukraine, which methods are already approved, and which are still being studied.
What Is Regenerative Medicine and How Does It Differ from Conventional Treatment?
Regenerative medicine is a field that aims to replace or restore damaged cells, tissues, and organs and return them to normal function. This is what sets it apart from conventional treatment. Until now, medicine has had three main approaches: removing the diseased tissue, repairing it with the patient’s own tissue, or replacing it with a donor organ. Regenerative medicine adds a fourth: restoration. The term itself came into wide use after 1999, when researcher William Haseltine used it at a scientific conference.
The History of Regenerative Medicine Worldwide
The history of regenerative medicine spans more than 70 years, from the first organ and bone marrow transplants in the 1950s and 1960s to the approved cell and gene therapies of the 2010s and 2020s.
Early Stem Cell Research in the 20th Century
1954: The first successful kidney transplant was performed between identical twins.
1968: A five-month-old boy with severe immunodeficiency received the first successful bone marrow transplant from a matched donor, his sister.
1970: Alexander Friedenstein’s group described bone marrow cells that were later named mesenchymal stem cells.
1978: Stem cells were identified in umbilical cord blood.
1981: The first mouse embryonic stem cell line was derived, and patients with burns received skin substitutes (bioengineered skin) for the first time.
Key Breakthroughs of the 1990s and 2000s
1991: Arnold Caplan proposed the term “mesenchymal stem cells”.
1998: Human embryonic stem cells were isolated for the first time.
2004: MSCs were used successfully in a clinical setting for the first time, to treat severe graft-versus-host disease.
2006: Patients with a bladder defect received bladders grown from their own cells.
The 2010s: Expanding Areas of Research
2012: The SafeCell meta-analysis, the first large-scale analysis of the safety of MSC therapy, found no association between cell administration and cancer or infections.
2014: In Japan, a patient with age-related macular degeneration received retinal cells derived from iPSCs for the first time.
2015: The EU approved Holoclar, the first stem cell-based product, for corneal repair after eye burns.
2017: The FDA approved Kymriah, the first CAR-T therapy in the US, for the treatment of a type of leukemia.
Regenerative Medicine Today: The Scale of Clinical Research (2020-2025)
According to the Alliance for Regenerative Medicine, 1,905 cell and gene therapy clinical trials were ongoing worldwide in the first half of 2025.
2023: Casgevy became the first FDA-approved gene-editing therapy based on CRISPR technology, for the treatment of sickle cell disease.
2024: Ryoncil became the first FDA-approved mesenchymal stromal cell product.
The Main Areas of Modern Regenerative Medicine
Modern regenerative medicine has four main areas: cell therapy, cell-free technologies, tissue engineering, and gene therapy. Three of them (gene therapy, cell therapy, and tissue engineering) share a common legal status in the EU, where they are classified as advanced therapy medicinal products (ATMPs).
Cell Therapy
Cell therapy involves administering specially prepared cells, either the patient’s own or donor cells, to the patient. Hematopoietic stem cell transplantation has the longest history of clinical use, while mesenchymal stem cell therapy is being actively investigated.
Cell-Free Technologies: Exosomes and Extracellular Vesicles
Instead of cells, these approaches use the substances that cells release, including exosomes: small extracellular vesicles through which cells exchange signals.
Tissue Engineering
Cells are combined with biomaterials, that is, scaffolds on which new tissue forms. This approach has already been used to create bioengineered skin, bladder, and corneal epithelium. Whole organs cannot yet be grown, because this would require recreating a branching vascular network.
Gene Therapy
Gene therapy modifies genes in a patient’s cells to target the underlying cause of a disease. For example, in Casgevy, the patient’s blood stem cells are edited using CRISPR/Cas9 technology. As a result, the body produces more fetal hemoglobin, which prevents red blood cells from becoming misshapen.
What Has Been Proven in Regenerative Medicine and What Is Still Being Studied
Official approval has been granted only to specific technologies for specific diseases, while most other approaches are still in clinical trials.
Already approved and in clinical use:
Hematopoietic stem cell transplantation for diseases of the blood and immune system;
CAR-T therapy for certain types of blood cancer;
Cell therapy for corneal repair after eye burns;
Gene therapy for sickle cell disease;
An MSC product for steroid-refractory graft-versus-host disease in children.
Still under investigation:
iPSC-based treatments;
Exosomes and other cell-free products;
Growing whole organs and 3D bioprinting.
Regenerative Medicine in Ukraine
Legal Regulation of Cell Therapy in Ukraine
The key document governing cell therapy facilities in Ukraine is Resolution No. 286 of the Cabinet of Ministers, dated March 2, 2016 (as amended in 2023 and 2025). It establishes the licensing requirements for umbilical cord blood banks and banks of other human tissues and cells, and specifies the premises, equipment, and staff a facility needs in order to obtain a license, including a biotechnology laboratory and a cryostorage facility.
The Law of Ukraine “On Medicinal Products” No. 2469-IX was adopted in 2022 to align Ukrainian regulations with EU legislation. It will enter into force on January 1, 2027.
Approved and Available Treatment Areas
Cell therapy in Ukraine is permitted within the limits set by legislation and licensing requirements:
Hematopoietic stem cell transplantation, including from living donors such as the patient’s relatives;
Storage of a person’s own cells, including umbilical cord blood, in licensed banks for possible use in future treatment;
Operation of umbilical cord blood banks and banks of other human tissues and cells under a license from the Ministry of Health of Ukraine. The ReoCell biobank holds such a license;
Clinical trials of cell-based products, which may be conducted only with authorization from the Ministry of Health.
Research and Medical Centers Advancing the Field in Ukraine
ReoCell (Kyiv) combines a biobank, cell product manufacturing, an R&D laboratory with its own vivarium, and a clinic.
How Regulation in Ukraine Differs from Approaches Worldwide
Regulation of Regenerative Technologies in the EU: Advanced Therapy Medicinal Products (ATMPs)
Under EU Regulation 1394/2007, gene therapy, somatic cell therapy, and tissue-engineered products are classified as advanced therapy medicinal products (ATMPs). They are evaluated by the Committee for Advanced Therapies of the European Medicines Agency (EMA), and the resulting marketing authorization is valid in all EU member states.
Cell and Gene Therapy in the US: How the FDA Evaluates Regenerative Products
In the US, cell and gene therapy products are evaluated by the FDA (the Food and Drug Administration). Each product is reviewed individually and approved only for a specific disease, and the list of approved products is published on the FDA website. To help promising regenerative therapies reach patients faster, the FDA has operated a special program, RMAT (Regenerative Medicine Advanced Therapy designation), since 2016. It speeds up the review of such therapies but does not waive the requirements for evidence of their efficacy and safety. At the same time, the FDA monitors the market: clinics that offer patients unapproved products receive official warning letters.
Regulation of Regenerative Medicine in Japan: An Accelerated Pathway to Clinical Use
In 2014, Japan enacted two laws regulating regenerative medicine. The Pharmaceuticals and Medical Devices Act governs how regenerative products are registered. It allows conditional, time-limited approval of a product after early-phase (Phase I-II) clinical trials. During this period, the manufacturer must confirm the product’s efficacy and safety; otherwise, the approval will not be extended. The second law, the Act on the Safety of Regenerative Medicine, applies to clinics. A clinic that uses cell-based technologies outside of registration trials must have its treatment plan reviewed by a certified committee and submit it to Japan’s Ministry of Health, Labour and Welfare.
Challenges and Limitations of the Field
Scientific and Technological Limitations
Embryonic and induced pluripotent stem cells can form tumors known as teratomas;
Growing organs requires recreating a network of blood vessels, which has not yet been achieved.
Regulatory and Ethical Issues
Obtaining embryonic stem cells raises ethical controversy because their source is an embryo;
Some clinics offer unapproved products, and patients have suffered serious complications after receiving them;
Regulations differ from country to country, so a method approved in one country may still be considered investigational in another.
Prospects for the Development of Regenerative Medicine
Today, the prospects of regenerative medicine are linked primarily to three areas: gene editing, therapies based on induced pluripotent stem cells (iPSCs), and the expansion of clinical research. The field is also becoming increasingly global: in 2025, the Asia-Pacific region surpassed North America for the first time in the number of cell and gene therapy trials.
Before agreeing to cell therapy, check the clinic, find out how well the method has been studied for your diagnosis, and have an in-person examination.
What to check about the clinic:
Whether it holds a Ministry of Health license to practice medicine and, if the clinic stores cells, a biobank license as well. You can view our documents on the Licenses and Permits page;
Where the clinic obtains its cell products and how it verifies their quality.
What to ask your doctor:
What evidence supports this method for my condition?
Is this an approved treatment or a clinical trial?
What are the possible risks and side effects?
What results can I expect?
Should I continue the treatment I am receiving now?
Only after an examination and tests can a doctor assess contraindications and decide whether cell therapy is right for you. If a clinic guarantees results or promises to cure any disease, be cautious.
Conclusion
Over more than 70 years, regenerative medicine has progressed from the first bone marrow transplants to approved cell and gene therapies. However, most technologies are still under investigation, and the rules governing their use differ from country to country. In Ukraine, cell therapy is regulated by the licensing requirements approved by the Cabinet of Ministers and by the Law “On Medicinal Products”. Whether cell therapy is suitable for a particular patient is decided by a doctor on an individual basis, after an examination.
Mesenchymal Stem Cells: What They Are, Where They Come From, and How They Work
Mesenchymal stem cells are the foundation of cell therapy at ReoCell. The center manages the entire process, from cell-based product manufacturing in its biotechnology laboratory to their clinical application by ReoCell Clinic physicians in traumatology, neurology, endocrinology, vascular surgery, dermatology, and other medical specialties.
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