FAQ

  1. 1. What is the Therapy provided by ITK?

    The Therapy:

    • consists in administration of a Product consisting of mesenchymal stem cells
    • 3 administrations during 6 months (time interval between the 1stand the 2ndAdministration is ca. 2 months),
    • method of Administration – the cells are administered by a puncture in the lower part of the spinal column
    • nature of medical treatment experiment.
  2. 2. Can I take part in the Therapy?

    Amytotrophic lateral sclerosis

    Criteria for the inclusion in Therapy - you should meet them in order to participate in the Therapy

    Exclusion criteria - if you meet at least 1 of the following criteria, you cannot participate in the Therapy

    1. Results of serological tests - HCV, HBV (jaundice type B and C), HIV, syphilis (VDRL/WR)
    2. Negative result of pregnancy test (beta HCG) in case of women up to 55 years
    3. forced vital capacity (FVC) in spirometry test above 50%
    4. declaration that the patient uses a non-hormonal contraceptive method, is not pregnant, does not breastfeed – applies to women, has not been diagnosed with active malignancy within the last 5 years, has not been diagnosed with chronic infectious disease, does not take antibiotics and non-steroidal anti-inflammatory drugs chronically, has not been a recipient of stem cells within the last 6 months, does not abuse alcohol, does not use drugs, signs the Informed Consent Form during a stay at the Institute, performs head MR examination after the end of Therapy, and will share the results with the Institute
    1. Patient’s failure to meet inclusion criteria for the participation in the Therapy
    2. cancer (diagnosed within 5 years before the qualification for Therapy)
    3. contraindications to perform a lumbar puncture
    4. active chronic infection
    5. uncontrolled hypertension, diabetes, thyroid and kidney diseases,
    6. pregnancy,
    7. breastfeeding,
    8. diseases requiring chronic intake of: non-steroidal anti-inflammatory drugs (including ASA therapy), corticosteroids, antibiotics, cytotoxic drugs
    9. positive results of serological tests
    10. the participation in stem cell therapy within the last 6 months


    Secondary-progressive multiple sclerosis

    Criteria for the inclusion in Therapy - you should meet them in order to participate in the Therapy

    Exclusion criteria - if you meet at least 1 of the following criteria, you cannot participate in the Therapy

    1. Patient gets 6-8 points in EDSS scale in the opinion of study neurologist
    2. Results of serological tests - HCV, HBV (jaundice type B and C), HIV, syphilis (VDRL/WR)
    3. negative pregnancy test (beta HCG) – in case of women aged up to 55 years
    4. declaration that the patient uses a non-hormonal contraceptive method, is not pregnant, does not breastfeed – applies to women, has not been diagnosed with active malignancy within the last 5 years, has not been diagnosed with chronic infectious disease, does not take antibiotics and non-steroidal anti-inflammatory drugs chronically, has not been a recipient of stem cells within the last 6 months, does not abuse alcohol, does not use drugs, signs the Informed Consent Form during a stay at the Institute, performs head MR examination after the end of Therapy, and will share the results with the Institute
    1. Patient’s failure to meet inclusion criteria for the participation in the Therapy
    2. cancer (diagnosed within 5 years before the qualification for Therapy)
    3. contraindications to perform MRI examination of the head
    4. contraindications to perform a lumbar puncture
    5. active chronic infection
    6. uncontrolled hypertension, diabetes, thyroid and kidney diseases,
    7. pregnancy,
    8. breastfeeding,
    9. diseases requiring chronic intake of: non-steroidal anti-inflammatory drugs (including ASA therapy), corticosteroids, antibiotics, cytotoxic drugs
    10. positive results of serological tests
    11. the participation in stem cell therapy within the last 6 months


    Rare neurodegenerative diseases

    Criteria for the inclusion in Therapy - you should meet them in order to participate in the Therapy

    Exclusion criteria - if you meet at least 1 of the following criteria, you cannot participate in the Therapy

    1. Patient gets 6-8 points in EDSS scale in the opinion of study neurologist
    2. Negative results of serological tests - HCV, HBV (jaundice type B and C), HIV, syphilis (VDRL/WR)
    3. negative pregnancy test (beta HCG) – in case of women aged up to 55 years
    4. declaration that the patient uses a non-hormonal contraceptive method, is not pregnant, does not breastfeed – applies to women, has not been diagnosed with active malignancy within the last 5 years, has not been diagnosed with chronic infectious disease, does not take antibiotics and non-steroidal anti-inflammatory drugs chronically, has not been a recipient of stem cells within the last 6 months, does not abuse alcohol, does not use drugs, signs the Informed Consent Form during a stay at the Institute, performs head MR examination after the end of Therapy, and will share the results with the Institute
    1. Patient’s failure to meet inclusion criteria for the participation in the Therapy
    2. cancer (diagnosed within 5 years before the qualification for Therapy)
    3. contraindications to perform MRI examination of the head
    4. contraindications to perform a lumbar puncture
    5. active chronic infection
    6. uncontrolled hypertension, diabetes, thyroid and kidney diseases,
    7. pregnancy,
    8. breastfeeding,
    9. diseases requiring chronic intake of: non-steroidal anti-inflammatory drugs (including ASA therapy), corticosteroids, antibiotics, cytotoxic drugs
    10. positive results of serological tests
    11. the participation in stem cell therapy within the last 6 months
  3. 3. What kind of documents need to be submitted for the qualification process?

    Amytotrophic lateral sclerosis

    • medical documentation confirming the diagnosis of the disease on the basis of Awaji criteria
    • forced vital capacity (FVC) in spirometry test above 50%
    • the results of serological tests - HCV, HBV (hepatitis type B and C), HIV, syphilis (VDRL/WR)
    • negative pregnancy test (beta HCG) – applies to women aged up to 55 years
    • patient statement containing the information on the use of non-hormonal contraception,  patient’s pregnancy and breastfeeding status – applies to women, the diagnosis of active malignancy within the last 5 years, the diagnosis of chronic infectious disease, chronic use of antibiotics, non-steroidal anti-inflammatory drugs, stem cell therapy within last 6 months, alcohol abuse, drug use, the signing of the Informed Concern form during the stay at the Institute, undergoing head MR examination following the end of the Therapy and sharing its result with the Institute.

    The declaration that should be filled out can be found in the documentation sheet for the medical treatment experiment.


    Secondary-progressive multiple sclerosis

    • medical documentation confirming the diagnosis of SPMS
    • patient’ score in EDSS assessment in the range of 6 to 8 points (in the opinion of attending neurologist)
    • the results of serological tests - HCV, HBV (hepatitis type B and C), HIV, syphilis (VDRL/WR)
    • negative pregnancy test (beta HCG) – applies to women aged up to 55 years
    • patient statement containing the information on the use of non-hormonal contraception,  patient’s pregnancy and breastfeeding status – applies to women, the diagnosis of active malignancy within the last 5 years, the diagnosis of chronic infectious disease, chronic use of antibiotics, non-steroidal anti-inflammatory drugs, stem cell therapy within last 6 months, alcohol abuse, drug use, the signing of the Informed Concern form during the stay at the Institute, undergoing head MR examination following the end of the Therapy and sharing its result with the Institute.

    The declaration that should be filled out can be found in the documentation sheet for the medical treatment experiment.


    Rare neurodegenerative diseases

    • medical documentation confirming the diagnosis of SPMS
    • patient’ score in EDSS assessment in the range of 6 to 8 points (in the opinion of attending neurologist)
    • the results of serological tests - HCV, HBV (hepatitis type B and C), HIV, syphilis (VDRL/WR)
    • negative pregnancy test (beta HCG) – applies to women aged up to 55 years
    • patient statement containing the information on the use of non-hormonal contraception,  patient’s pregnancy and breastfeeding status – applies to women, the diagnosis of active malignancy within the last 5 years, the diagnosis of chronic infectious disease, chronic use of antibiotics, non-steroidal anti-inflammatory drugs, stem cell therapy within last 6 months, alcohol abuse, drug use, the signing of the Informed Concern form during the stay at the Institute, undergoing head MR examination following the end of the Therapy and sharing its result with the Institute.

    The declaration that should be filled out can be found in the documentation sheet for the medical treatment experiment.

  4. 4. How much time lapses from becoming registered at the Institute until commencement of the Therapy?

    up to 60 days

  5. 5. How does the hospitalisation process progress?

    During each visit the Patients stays approximately 24 hours in the Institute.

    Day 1 – acceptance of Patient to the Ward, final qualification, entering the Patient in the Research Programme, administration of the MSC Formulation;

    Day 2 – discharge.

  6. 6. Where do the cells used in Therapy come from?

    The therapy is carried out with the use of the Product based on mesenchymal stem cells.

    These cells are isolated from the umbilical cord and they are the basis for the generation of a Product dedicated to a specific patient.

    Umbilical cord is obtained from healthy donors during childbirth and this procedure is preceded by medical interview with the donor's mother, blood tests of the donor's mother as well as obtaining mother's written consent regarding the acquisition of umbilical cord tissue and the obtaining of a waiver of all rights in the biological material.

    The Laboratory of the Polish Stem Cells Bank, which has the relevant licenses of the Main Pharmaceutical Inspectorate and the National Centre for Tissue and Cell Banking is the supplier of cells used in the Therapy. The product is manufactured individually for each patient at the request of a physician from the Institute's Medical Team. The manufacturing of a Product lasts about 1 - 1.5 months.

    There is a possibility to use in the Therapy cells from related donors, whose material is deposited at the Polish Stem Cell Bank. In this case, it is necessary to stick to an appropriate degree of consanguinity between the related donor and the recipient (the donor = child during whose birth umbilical cord was collected, the recipient = Patient undergoing Therapy). Such cells can be used in Therapy of biological parents of this child or his grandparents.

  7. 7. What is the cost of the Therapy using the MSC Product?

    Information may be found in the bookmark Price List in the Section for the Patient.

  8. 8. In what form should the payment be effected?

    The payment is to be done as a bank transfer – bank account number: mBank 31 1140 1010 0000 2808 1200 1001, SWIFT: BREXPLPWMBK, IBAN: PL

  9. 9. Is the Therapy subject to refund by the State Health Fund?

    The Therapy is a medical treatment experiment. For this reason no refund may b made under the State Health Fund.

  10. 10. What should be done before I come to the Institute?

    14 - 10 days before cells administration, you should test the following:

    • general morphology,
    • APTT
    • CRP
    • INR

    Send the results in electronic form to the following address: m.wojtkowska@itkmed.pl no later than 2 days before cells administration.

    Incorrect test results or failure to send them to the Institute at the above-mentioned date may result in the postponing of the Therapy.

  11. 11. What items should be brought to a visit in the Institute?

    • everyday use personal items - slippers, bathrobe, pyjamas etc.
    • identification documents of the Patent (e.g. ID card, passport,),
    • medical documentation submitted to the Institute beforehand, if previously it had been in an electronic form
    • any medications taken by the Patient including instructions given by relevant physicians
  12. 12. Can a guardian / family member stay with the Patient in the Institute for the duration of the Therapy?

    Yes. Each room has been set up in a comfortable way, to meet requirements not only of the Patients, but also accompanying persons. Each room has additional beds.

  13. 13. What happens if a Patient is unable to keep the agreed appointment for Administration?

    In such a situation we agree a new date.

  14. 14. Will the Patient receive a meal?

    Yes. During the proper visit in the Institute the Patient gets three meals.

  15. 15. Will the Patient be able to withdraw at any time from the Therapy?

    Yes. Participation in the Therapy is voluntary. The Patent may withdraw from participation in the experiment at any time.