Kyiv, Symona Petliury St., 28
+38 (096) 515 79 79
+38 (093) 414 79 79
We live in the 21st century. Never in its history of ups and downs has humanity achieved such a level of development as we have, crossing the threshold of the third millennium. In the last century, humans soared into space, explored the depths, and began unraveling the mysteries of the universe. In this century, we boldly delve into the secrets of the microcosm, studying the capabilities and mechanisms of our own organisms at the subcellular level.
Plasmotherapy is a method for treating numerous diseases and maintaining the beauty and health of our bodies. It is based on the ability of our blood cells and their constituent proteins to exert a therapeutic effect on the targeted area.
For researchers, it is no secret that plasmotherapy, or treatment with autologous plasma, originated in the early 20th century with autohaemotherapy, pioneered by our compatriot, a graduate of Kyiv University, physician, and later priest, Valentin Feliksovich Voyno-Yasenetsky, who was canonized as a saint. By the 1950s, these methods gradually entered clinical practice. However, they were not particularly popular due to the limited material and technical resources for research. While some effects were observed, the mechanisms, tissues affected, and precise actions remained unclear, hindering the method’s development.
In the 1990s, a revolution occurred with the decoding of plasma’s protein composition and the identification of platelet growth factors. Building on this knowledge, American scientists developed platelet-rich autologous plasma, initially used in dentistry and maxillofacial surgery. I am proud to say that one of the greatest doctors and researchers, Dr. Robert E. Marx, was an honored guest and speaker at the PRP World Summit organized by our company. The last 20 years have marked a breakthrough in plasma research and application, expanding beyond dentistry into traumatology, dermatology, gynecology, urology, ophthalmology, surgery, and many other medical fields.
Hundreds of scientific studies, both in Ukraine and abroad, substantiate its clinical efficacy, minimal risk of complications, and absence of side effects. Unfortunately, this method remains “invisible” at the regulatory level in Ukraine. This is due to several factors: a lack of fundamental biochemical and clinical plasma research at the national level to integrate into the regulatory framework; slow adaptation of advanced countries’ clinical guidelines; and, most critically, the low level of funding for Ukrainian medicine and bureaucratic hurdles that drown good ideas in a swamp of approvals, permits, and competing interests. A breakthrough in this regard was the decision by former Acting Minister of Health Ulyana Nadia Suprun to allow doctors to use modern global protocols and guidelines. The corresponding Ministry of Health Order No. 1422 of December 29, 2016, came into effect on April 28, 2017, and we will return to it later.
When discussing plasmotherapy, we must understand it as autoplasmotherapy—treatment of a patient’s condition using a blood component, plasma, or platelet-rich fibrin with specific characteristics derived from the patient’s own blood. Is autologous plasma a medicinal product? No—according to Order No. 426 of August 26, 2005, the legislator defines medicinal products derived from human blood or plasma as those industrially manufactured at state or private enterprises, including albumin, blood clotting factors, and human immunoglobulins. Industrial production implies systematic blood processing to extract specific substances, conducted under technical conditions that pass sanitary-hygienic evaluation, with an implemented quality system and certified medicinal products. In autoplasmotherapy and its variations, the blood component itself—plasma—is used with specified characteristics, without isolating individual substances.
The legality of medical interventions, including plasmotherapy, consists of several elements.
The primary and fundamental element is the patient’s informed consent, as stipulated in Article 43 of the Law of Ukraine “Fundamentals of Ukrainian Legislation on Healthcare.” The Constitution of Ukraine guarantees every citizen the right to healthcare, medical care, and medical insurance. The state creates conditions for effective and accessible medical services for all citizens. The Law “Fundamentals of Ukrainian Legislation on Healthcare” states that every citizen has the right to healthcare, a standard of living (including food, clothing, housing, medical care, and social services) necessary to maintain human health; a safe environment for life and health; sanitary-epidemiological safety of their territory and place of residence; safe and healthy conditions for work, education, living, and recreation; and qualified medical-sanitary assistance, including the free choice of a doctor and treatment methods. Thus, the key criterion for determining a treatment method, including plasmotherapy, is the patient’s choice, formalized in an informed consent document signed after receiving reliable and comprehensive information about their health condition. It is the medical professional’s duty to provide the patient with accessible information about their health status, the purpose of proposed examinations and treatments, and the prognosis, including potential risks to life and health. Legislation provides for Form 003-6/o, “Informed Voluntary Consent for Diagnosis, Treatment, Surgery, and Anesthesia,” which is general in nature and, as practice shows, must be included in the medical record of an outpatient or inpatient, as well as in cases of pregnancy termination and birth records.
This is the carte blanche, the starting point for any examination or treatment. However, signing this document does not guarantee that a doctor’s actions will be deemed lawful. To protect themselves, doctors must provide the patient with comprehensive information about their health status and diagnosed or treated conditions. Most doctors do this orally, which is sufficient for most patients. However, law enforcement or some legally savvy but unscrupulous patients may argue otherwise. The legislator uses the term “accessible form of information provision,” which can be interpreted against the doctor, as the use of specific professional terms may be unclear to the patient, rendering the signing of Form 003-6/o invalid. Therefore, I recommend documenting patient information under signature at every visit, including details in the outpatient, inpatient, or dental medical record about their health, history, and diagnosis. Additionally, medical documentation should include informational leaflets about the condition and treatment methods.
Example 1.
Alopecia Areata
Alopecia areata is a condition characterized by circular, non-scarring hair loss on the scalp, face, and other areas of smooth skin.
Symptoms
Hair loss on the scalp, torso, and/or limbs. Recent lesions appear red, with broken hair at a few millimeters along the periphery. Long-standing lesions are indistinguishable from normal skin. The disease progression varies:
Lesions appear without prior symptoms; hair regrowth may occur spontaneously within 2–6 months without treatment; recovery may be incomplete, with the disease taking a chronic course where some lesions regrow while new ones form; the condition may occur once or recur after an indeterminate period.
Patients may exhibit characteristic nail changes: thimble-like (punctate) indentations, longitudinal striations, wavy patterns on the free edge (the part of the nail extending beyond the fingertip); such changes occur in one-fifth of patients with limited forms and in most cases with severe (total or universal) forms.
Diagnosis:
1. Laboratory Tests:
– Complete blood count
– Urinalysis
– Biochemical liver function tests (total bilirubin, AST, ALT, total protein, glucose, cholesterol, alkaline phosphatase)
– Serological tests (RW, RPR)
– Blood cortisol levels (before systemic corticosteroid treatment and 3 weeks after completion)
– Blood sex hormone levels (estradiol, testosterone, FSH, LH)
– Blood thyroid hormone levels (T3, T4, TSH).
2. Instrumental Tests
– Fluorography
– Skull X-ray or tomography
– Rheoencephalography
– Thyroid ultrasound (if indicated)
– Hair microscopy from the lesion’s edge (before treatment)
– Microscopic examination of skin scrapings for fungi (before treatment).
3. Consultations with Related Specialists (if indicated)
– Endocrinologist
– Neurologist
– ENT specialist
– Gynecologist
– General practitioner.
Treatment Program
1. Elimination of chronic infection foci.
2. Correction of identified concomitant pathology.
Systemic Therapy
– Microcirculation enhancers (pentoxifylline, xanthinol nicotinate, ticlopidine, nicotinic acid).
– Sedatives (valerian, 3% sodium bromide solution, motherwort, peony).
– Antistress adaptogens (glycine) or tranquilizers (hydroxyzine) if needed.
– Vitamins and trace elements (calcium pantothenate, thiamine, nicotinic acid).
– Biogenic stimulants (aloe, methyluracil, placental extract, sodium nucleinate).
– Cerebral blood flow enhancers (if indicated) (cinnarizine, vinpocetine).
– Anabolic hormones (if indicated) (retabolil, phenobolin).
– Phytotherapy (decoctions of horsetail, succession, yarrow, knotgrass, nettle).
– Physiotherapy (electrosleep, phonophoresis, Darsonval, cryomassage, PUVA therapy).
Topical Therapy
– Subcutaneous glucocorticoid injections into lesions (betamethasone, triamcinolone).
– Irritants (tincture of capsicum, onion juice, garlic juice, burdock root tincture, horseradish, topical glucocorticoids).
– Plasmotherapy: 6 sessions with a 10-day interval.
Treatment Duration
Mild forms of alopecia areata are treated for 2–4 months on an outpatient basis.
Expected Treatment Outcomes
Hair regrowth (initially vellus, later terminal).
Treatment Quality Criteria
Revitalization of the follicular apparatus, cessation of hair loss, hair regrowth.
Possible Side Effects and Complications
Subcutaneous glucocorticoid injections may cause atrophy at injection sites. Individual drug intolerance is possible.
Recommendations for Further Medical Care
If treatment is ineffective, systemic and topical therapy should be adjusted. Concomitant pathology treatment should be intensified. Hair transplantation may be considered. Patients require ongoing monitoring at their place of residence. Treatment courses should be repeated 2–3 times per year. Chronic infection foci and intercurrent diseases must be monitored. After inpatient treatment, adaptogens, general tonics, and topical physiotherapy are recommended.
Dietary Requirements and Restrictions
No restrictions. Food should be enriched with vitamins and trace elements.
Labor, Rest, and Rehabilitation Requirements
Work involving aggressive chemicals, radioactive substances, or psychoemotional stress is contraindicated. Rest is unrestricted.
Systematic follow-up with related specialists as needed: neurologist, endocrinologist, gynecologist, gastroenterologist, ENT specialist, dentist. Alopecia does not affect general health but poses a cosmetic issue, requiring psychological rehabilitation.
Patient ________________________________ acknowledges that the nature of their condition and treatment has been explained in an accessible manner, and they have no questions or complaints against the medical professional.
“______” ________ 202_____ Signature_________________________
The next document I recommend introducing into documentation is the “Individual Examination and Treatment Plan.” This is essentially a checklist of recommended examinations and procedures for the patient, with specified timelines. While it duplicates some entries in the outpatient, inpatient, or dental medical record, it additionally confirms the patient’s consent to specific diagnostic and treatment procedures, including plasmotherapy.
Example 2
Individual Examination and Treatment Plan*
Patient ____________________________________________________________________
Diagnosis: ____________________________________________________________________
| Procedure | Planned Date | Patient Signature |
| Diagnostics | ||
| 1. Laboratory Tests | ||
| 2. Instrumental Tests | ||
| 3. Referral to Related Specialist | ||
| 4. Recommended Medications | ||
| 5. Medical Interventions | ||
* Depending on the disease progression and treatment efficacy, this plan may be adjusted.
Doctor ____________________________________/________________/
Now, let’s return to the methods and their connection to informed consent. As mentioned earlier, plasmotherapy is not reflected in the Ministry of Health’s regulatory acts. According to Article 44 of the Fundamentals of Ukrainian Legislation on Healthcare, medical practice may employ prevention, diagnostic, treatment, and rehabilitation methods, as well as medicinal products, approved for use by the central executive body responsible for shaping healthcare policy. The Ministry of Health has not approved a unified list of treatment methods; however, they are included in medical-technological documents for standardizing medical care based on evidence-based medicine—clinical protocols.
What can Ukrainian doctors rely on in daily practice:
Unified clinical protocols contain no mention of plasmotherapy. Therefore, the primary system for us is the so-called new protocol. How to adopt it? Visit https://moz.gov.ua/article/protocols/test3, follow the links, and search for clinical guidelines for diagnoses treated with PRP or PRF therapy. Translate the identified clinical guideline into Ukrainian and approve it through an order by the chief physician for use in the medical institution as a “new diagnostic and treatment protocol.”
However, this system has a drawback: recommended clinical guidelines permitting plasmotherapy cover 90% of conditions in dentistry and traumatology. This is because these fields have historically developed plasmotherapy since the 1990s, making them the most widely studied and popularized in the scientific community. What should doctors in other specialties do?
Many treatment methods in reconstructive and aesthetic medicine, as well as plastic surgery, are “outside” regulatory frameworks. For example, mammoplasty, abdominoplasty, and the use of hyaluronic acid preparations, performed daily in numerous clinics across Ukraine, lack clinical protocol backing.
However, our legislator has provided a unique opportunity to apply methods not covered by medical-technological documents.
These are called “New methods of prevention, diagnosis, treatment, and rehabilitation” and are also provided for in Article 44 of the Fundamentals of Legislation. New methods of prevention, diagnosis, treatment, rehabilitation, and unregistered medicinal products under consideration but not yet approved may be used in the interest of a patient’s treatment only after obtaining their written consent. When obtaining consent for new methods or unregistered medicinal products, the patient and/or their legal representative must be provided with information about the goals, methods, side effects, potential risks, and expected outcomes.
Therefore, I recommend providing an additional informed consent form specific to plasmotherapy, in addition to Form 003-6/o, for all interventions, not just those not covered by “new protocols.”
Below is an example of informed consent for PRP therapy. For other types of plasmotherapy, including modified plasma forms, separate consent forms exist.
Example 3.
Informed Consent
for the Procedure of Autoregeneration Stimulation with Platelet-Rich Plasma PRP (Professional).
I, _____________________________________________,
Age _________________, Phone _____________________,
Authorize the PRP (Professional) procedure to be performed by Doctor ________________________________________________.
I have been informed that PRP (Professional) involves the injection of platelet-rich plasma, obtained from my own blood, into the treatment area ___________________________.
The procedure is performed under local anesthesia.
PRP (Professional) is a safe and effective procedure designed for accelerated, full tissue regeneration. The treating physician has thoroughly explained the indications for the PRP (Professional) procedure and its process. I had the opportunity to receive comprehensive answers to my questions. My attention was drawn to the fact that temporary reactions typical of injection procedures may occur, such as erythema lasting several hours or days, pain, and possible hematomas at injection sites. In rare cases, exacerbation of herpes infection may occur post-procedure. With proper adherence to the doctor’s recommendations, complications are typically absent.
The doctor also informed me that, depending on the indications, I may need a course of procedures to achieve the desired result.
I have provided sufficient information about my health status, including chronic conditions. I have been advised not to consume alcohol 24 hours before and after the procedure and to follow all the doctor’s recommendations.
By signing, I confirm that I am not pregnant or lactating, have no allergies to heparin, no autoimmune, oncological, hematological, or immunodeficiency conditions, am not using glucocorticoid drugs, and have no tendency to form keloid scars. Otherwise, after receiving explanations from the doctor, I take responsibility for all consequences.
Patient Signature ____________________
Doctor Signature _______________________
Date “____” __________________ 202 ___
It’s worth mentioning the equipment for producing plasma products. You can use any test tubes, and the resulting material may technically be called “plasma” or “fibrin.” However, the devil is in the details. Medical devices are divided into “in-vitro” and four safety classes. In-vitro devices are intended for diagnostics, meaning you cannot use a product that directly contacts the surface of such a device for medical interventions on a patient. The sterility and genotoxicity requirements for in-vitro devices are significantly lower than for in-vivo medical devices of safety classes 2 and 3. This applies to test tubes, but not to centrifuges, as the latter do not directly contact blood or plasma products.
Therefore, I recommend using only test tubes that have passed conformity assessment under Technical Regulation 753, are certified by an authorized Ministry of Health body, belong to safety classes 2 or 3, and are intended for plasmotherapy, PRP, or PRF therapy. There are few such products on the market, and they are significantly more expensive than laboratory test tubes. Personally, I recommend MM Medic products, which meet all the above requirements, as I use them myself.
Conclusions:
The use of plasmotherapy, like any other treatment method not included in unified clinical protocols but not prohibited, is entirely legal when properly implementing “new protocols” in medical practice and/or preparing documentation based on maximum patient information, combined with the use of certified medical devices.