PROTOCOL COMPARISON

HSCT FACILITY
Questions from EU patients with Multiple Sclerosis
From the interview below you can find out more details about the difference in protocols.

Interviewer Noëlle Tassy (France)
Noëlle
French patients who want HSCT can no longer get visa to go to Moscou?
I understand it may sound strange, but paperwork has become much easier with the advent of a 90-day tourist visa. Visa application package, including advanced travel insurance with full coverage of treatment in case of covid infection, is sent along with a step-by-step guide to filling out the online application and in 3-10 days the visa is ready. Processing goes very smooth and easy due to the low workload of the consular offices. Most often, the patient does not even have to leave the house to get a visa and are able to manage it by post.

Unfortunately, there is no direct flights to Moscow, so patients have to take flight tickets with connection in Istanbul, Belgrade or Dubai. The number of flights between these countries has been significantly increased, so it's not a challenge to get the tickets.
Noëlle
Treatment in Mexico and Russia are often compared.
Treatment in Mexico can be compared to Moscow, mainly in terms of the cost. In all other respects, we should not put them in the same row, It's a bit unfair, it's like to compare a wellness hotel and a university multidisciplinary hospital. Clinica Ruiz is more of a commercial project, and because of this, of course, it has a number of advantages in terms of comfort of accommodation and other services. In terms of safety and effectiveness, Mexico is certainly not comparable to University Hospitals such as Northwestern University in Chicago, Heidelberg University Hospital in Germany, Careggi University Hospital in Italy, as well as National Medical Surgical Center.

University Hospitals are licensed and funded by the government and have unparalleled scientific and technical capabilities to carry out assigned tasks with maximum efficiency and safety, meantime conducting continuous scientific activities to develop, optimize and implement high requirements for ensuring the quality of treatment and patient safety.

Noëlle
What is the main difference between treatment in Russia and Mexico?
Let's start with the main goals of this quite expensive method of treatment:

1. Complete elimination of the defective immune system, the main cause of the disease.

2. Launching a new immune system, absolutely without any traces of the disease.

To achieve the first goal, we need a high-dose chemotherapy and what is more important, effective and safe applying of this chemotherapy.

Otherwise, this treatment has no difference from traditional therapy, where you're unable to get rid of the disease and have to continue taking pills forever.

At first glance, the both protocols look the same, total load of Cyclophosphamide also the same, but the main difference is in applying chemo:

Our conditioning regimen suggests 50 mg. per kg. weight continuously for a 4-day course, and what is the most important: without interruptions!

The conditioning regimen in Mexico is different, the first injection of Cyclophosphamide 100 (mg per kg of body weight), and then you have a break for a whole week until the second injection.

The fact is that after a single intravenous administration, the content of Cyclophosphamide in the blood plasma tends to rapidly decrease during the first 24 hours.

Studies show that after 72 hours it is still possible to detect their content in the blood, but this amount becomes negligible.

The fact is that after a single intravenous injection, the content of Cyclophosphamide in the blood plasma tends to decrease rapidly during the first 24 hours.

Studies show that it is still possible to detect their content in the blood plasma after 72 hours, but this amount becomes negligible.

Consequently, after the first administration of Cyclophosphamide, the pharmacological effect does not have time to develop, and over the course of a week (168 hours), all Cyclophosphamide is safely eliminated from the body.

Only 4 days of continuous immunosuppression leads to neutropenia. In this state, you simply have no chances to survive outside the aseptic unit.

The «Mexican method» conditioning regime is more a formality, they split the chemo into two batches of two sessions one week apart. After each session you are able to return to the hotel or go sightseeing.

Therefore, people planning HSCT in Mexico should realize, that carried procedure can partially reduce the disease, but definitely can't eliminate it. It is important!

Those who did not realize that, after several years of observing negative dynamics, comes to us in order to perform a real HSCT (HDIT with AHSCT), in accordance with the original protocol.
Noëlle
Some of the patients, who are very badly informed about HSCT facilities and protocols, start to go to India where 2 facilities are trying to take advantage of the geopolitical context to attract MS patients, using commercial arguments ("best facility in the world"), a JCI-USA accreditation (which has nothing to do with HSCT) and price ($30,500).
Accreditation means that the clinic meets the requirements of the Ministry of Health. In terms of requirements for the premises, equipment of the clinic, staff qualifications.
A clinic thinking about performing CM transplants receives an accreditation/license from its Ministry of Health. Serious work with cellular technologies, in particular with stem cells throughout the world, is the prerogative of the government in view of the complexity of the processes and the requirements for personnel qualification.

Noëlle
These facilities are not endorsed by the international Facebook admin (George Goss, Carol Ola Vera,...) because of their weak experience with HSCT for MS (200 patients), no publications and big safety concerns (deaths, severe infections, errors in drug prescriptions...).
Artemis and Fortia hospitals assert they have increased their reception capacity to compensate for the inaccessibility of Russia.
I will not write much about the Indian protocol, everything is obvious here, this is an extremely dangerous practice based on the very first steps in this area.
Especially considering that Artemis protocol using Antithymocyte Globulin (rATG) according to the published studies of Dr. Fedorenko and Dr. Burt - it causes allergic reactions in 30% of patients (in most cases severe up to shock). And every such patient had a relapse of MS within a year after AHSCT.
Noëlle
What are the benefits of American accreditation in India?

Permission for transplants?

It is unlikely that the Ministry of Health of one country in such an important issue of protecting the health of citizens will accept the requirements of another country. Due to the difference in staff training, difference in climate, difference in treatment approaches, experience gained, etc.

The clinic, which flaunts the accreditation of another Ministry of Health, thus admits that the medicine of our country is so bad that we have received accreditation from another country for patients to somehow correct this shortcoming. Although she does not give us anything. But we got. It also allows us to compensate for the lack of presence in the international scientific school by the presence of a loud slogan. "We are accredited to JCI-USA.". In the true scientific community, the accepted formats of interaction with authoritative specialists are training for the formation of qualified personnel, joint work to reach new heights. But not worship to mislead patients.

In the case when the manipulations performed do not fall under the term treatment, accreditation is not needed. In this case, the presence of foreign accreditation gives the illusion that this institution provides treatment according to American standards. In reality, however: in rooms that meet the requirements of the American Association, manipulations are carried out that imitate the AHSCT process. In order not to fall under the regulation of India, Mexico and not be liable. But so that patients have the feeling that they are being treated according to the most advanced standards.

Noëlle
I and other MS patients are very worried about this situation. I informed MATHEC in Paris (Pr Farge) who seem to share our concerns but say at the same time that they need objective data and mention the importance for FACT or JACIE accreditations.
JCI is the most established company in the US market of international accreditation systems for medical organizations
The purpose of the JCI standards is to create security mechanisms.
Its standards make it possible to create safe conditions for the provision of medical care, to determine quantitative indicators of the quality and safety of processes in an organization, and to expand the possibilities for improving the level of competence of medical workers.
The standards are based on the prevention of the risks of infections associated with the provision of medical care, the correct identification of the patient's identity, the safety of the use of medicines and medical devices, the implementation of pain relief measures, as well as the prevention of systemic and most common slips in medical activities. For example, so that the surgeon does not amputate the wrong limb to the patient by mistake.
The presence of such accreditation is especially useful for commercial clinics, the presence of a single standard inspires confidence among patients from different parts of the world, which contributes to the export of medical services.
Noëlle
What are the benefits of accreditation in general?
Accreditation is a local standard that confirms that the hospital has the necessary equipment and staff. Russia has very strict regulation and accreditation by the Ministry of Health.

Transplantation can only be carried out by state university centers. If some hospitals have European or American accreditation, this does not mean that they provide the best treatment.

All transplant research believes that centers that treat autoimmune diseases should have experience and experienced staff in this area. Accreditation alone is not enough to ensure safe treatment. All centers must be accredited in accordance with local government regulations, and we have it. Accreditation ensures that we have a department, equipment, personnel and we comply with Russian rules and safety standards. But long-term experience is much more important - the opinion of patients, the opinion and recognition of other specialists, statistics, conferences and scientific articles. The most significant indicator in transplantation is a membership of the Pirogov Center in the EBMT medical and scientific organization.



Noëlle
How are accreditation requirements formed?
In accordance with the development of this direction. The higher the scientific and empirical experience, the development of progress in general, the higher and fuller the requirements. Incl. and treatment protocol.

In the Russian Federation, at the legislative level, strict requirements have been established for the organization and conduct of internal quality control and safety of medical activities, which is especially well implemented in state medical institutions.

All Federal Government Budget Institutions are supervised by many higher regulatory authorities, such as the Ministry of Health, Federal Department for Control in Healthcare,

Federal Service for Supervision of Consumer Rights Protection and Human Welfare, Department of Health of the City of Moscow.

Moreover, in Russia, for more than a century, there have been entire national quality institutes that conduct continuous scientific activities to develop, optimize and implement high requirements for ensuring the quality of treatment and patient safety.

The Pirogov Center is one of the flagships of the Russian advanced medicine, a benchmark in the provision of quality medical services based on the use of modern high-tech methods of diagnosis, treatment, rehabilitation and prevention.

Noëlle
What about efficiency and safety?
These are research, continuous experience, educational programs, preparation of a scientific school. Our University Hospital is a member of the scientific EBMT, regularly publishes in specialized authoritative publications, holds and participates in international conferences.
Noëlle
As far as I know, "HSCT Russia" has published several times, has hosted an international HSCT for AID disease Conference in 2019, has transplanted about 1500 MS patients but has no accreditation, which is not an obstacle for international patients since you are very renowned for your experience and results.
Yes, during the 16 years of practice, in total was performed about 3,000 of various transplantations in a single department, including about 2000 foreign patients.
Currently we are the one of the largest single center experience, practical experience in the world.
You can find this information on the Internet; the most recent ones are published on our website, for example:

New Lymphoablative Conditioning Regime for Relapsing-Remitting Multiple Sclerosis (RRMS)

Clinical Studies - low-Intensity conditioning regimens in RRMS

Clinical and Patient-Reported Outcomes of HSCT (Mainly focused on SPMS, RRMS)
MULTIDISCIPLINARY UNIVERSITY HOSPITAL
"NATIONAL MEDICAL AND SURGICAL CENTER"
National Scientific Facility belongs to Federal Strategic Objects and located on the closed area on the edge of Moscow City. Fully autonomous medical complex consists of eighteen specialized departments supervised by own maintenance infrastructure - it's like a small town in a big city, that provides high-quality medical care based on the use of modern high-tech methods of diagnosis, treatment, rehabilitation and prevention.
THE LIST OF DEPARTMENTS OF THE HOSPITAL
1. Department of cardiovascular surgery
2. Department of diagnostic and operative endoscopy
3. Department of gastroenterology
4. Department of gynecology
5. Department of maxillofacial surgery
6. Department of medical rehabilitation
7. Department of neurology and clinical neurophysiology
8. Department of surgery №1
9. Department of surgical treatment of complex heart rhythm disorders and pacing
10. Department of traumatology and orthopedics №1
11. Department of traumatology and orthopedics №2
12. Department of ultrasound and x-ray surgical methods of diagnosis and treatment
13. Department of x-ray surgical methods of diagnosis and treatment
14. Hematology, antitumor drug chemotherapy and marrow transplantation department
15. Neurosurgery department №1
16. Neurosurgery department №2
17. Ophthalmology center
18. Department of neurology for patients with cerebral circulation disorders
ALL-INCLUSIVE CONTRACT
Contract is your guarantee for success and covers any unforeseen situation.
Provisions were created taking into account all the necessary conditions for the successful implementation of the treatment program for a foreigner, who arrived without any additional assistance or accompany.
The cost of the contract is fixed and Includes all necessary conditions:
Pre-transplant examinations including non-core diseases & ICU procedures if necessary. Accommodation & 24/7 observation by qualified & experienced medical team of the multidisciplinary Hospital. Nutrition and care are tailored to the individual needs of each patient. Visa & booking assistance, meeting and transfers are also included, therefore, all that remains for the person - is to buy a round-trip tickets.

Your good mood and confidence is one of the components of successful treatment. Implementation of it takes start for us from the day you've completed questionnaire.
The provision of assistance and guidance on a medical examination procedure and subsequent treatment at a specialized medical institution in the Russian Federation.
Localization of medical records, tests, specialized reports and other documents by involving a specialized organization.
Providing relevant information to the patient, in order to make an independent decision, taking into account analyzed medical records and reports on the results of completed forms & questionnaires.