Below you will find answers to many frequently asked questions by patients regarding stem cell treatment at Luna Laboratory. If you need additional knowledge or clarification of doubts, please contact us - we will answer all your questions and we will try to provide you with the information you need.
1. Is cell therapy used by Luna Laboratory a method of MS treatment authorized for use in Poland?
Yes, the method of MS treatment applied by Luna Laboratory is implemented in Poland on the basis of authorization/consent issued respectively by the Minister of Health, the Chief Pharmaceutical Inspector and the Bioethical Commission at the District Medical Chamber in Lodz by means of decisions.
The stem cell selection procedure used by Luna Laboratory is certified for clinical use and has been recognized as safe, approved by the Bioethics Committee for use in Poland for therapeutic purposes.
2. Is treatment with this method refunded by the NFZ?
No, MS therapy using stem cells is currently not refunded by the NFZ.
Due to the very good and documented effects of treatment, we strive to ensure that the therapy is reimbursed by the NFZ, and thus became available to a larger number of patients.
3. What therapeutic effects can I expect? How fast can I expect them? Should therapy be repeated?
Each treatment and every patient is an individual case, therefore it is impossible to predict what therapeutic effects will occur and how quickly. Nevertheless, in all four patients we have been subjected to individual cell therapy so far, a significant improvement in health has been found.
Patients' follow-up studies confirmed relief or complete relief of symptoms such as: sensory disturbances, visual disturbance, balance disorders, limb paresis, spasticity, and chronic headaches. According to the patients' reports, some noticed improvement in health and well-being after only 3 months after surgery, others after 6 months.
Autologous transfer of bone marrow stem cells is a one-off procedure.
The therapeutic effect in the group of patients who benefited from it lasts 4 years.
4. Is stem cell therapy safe?
The bone marrow stem cells used in therapy do not show immunogenicity and are therefore not treated by the body as a transplant and are therefore not discarded.
In addition, the drug developed by Luna Laboratory and administered during the therapy is manufactured on the basis of the patient's own stem cells, which excludes the risk of transmission of diseases, the occurrence of a serological conflict or allergic reactions
5. Is there a risk associated with the graft procedure?
None of our patients had complications during the transfer of stem cells. Taking a small amount of bone marrow is a relatively simple and minimally invasive process.
During standard procedures (e.g. in the treatment of leukemia) approximately 1000-1500 ml of bone marrow are taken, while in the therapy we recommend, this amount is limited to 50ml, therefore the patient's body is regenerated much faster. There may be pain in the place of bone marrow collection, usually disappearing after a few days. There is a minimal risk of tissue damage, infection or inflammation at the injection site. This risk, however, is very small due to strict adherence to the sterility rules during the procedure, as well as the selection of highly qualified hospital staff and medical staff. Serious symptoms and sequelae are extremely rare. There are no complications reported in Poland or in the world.
Bone marrow bone harvesting procedures may also be associated with very rare complications associated with local anesthesia, i.e. anaphylactoid symptoms, agitation, anxiety and drowsiness.
Patients who have collected bone marrow throughout their further hospitalization are subject to follow-up to rule out possible adverse events.
6. Are there examples of patients treated with stem cells in Luna Laboratory? How did the therapy work in their case?
Yes, there are such patients. In 2014, four patients suffering from MS were treated with individual cellular therapy, as a result of which all of them had a significant improvement in health and serious reinforcement of the body.
Depending on the case, the symptoms, such as visual disturbances, balance disorders, limb paresis, spasticity, and sensory disturbances were alleviated or completely resolved.
Our previous experience shows that the therapeutic effect in a pilot group of patients can be observed for 4 years after a single use of autologous stem cells selected from the bone marrow. The therapeutic effect is progressing, and patients who have used our therapy are currently monitored clinically. Neurological assessment and magnetic resonance diagnostics in these patients are still ongoing due to the continually progressive and sustained therapeutic effect.
Thus, it can be concluded that the therapeutic effect of a single transfer of autologous stem cells selected from the bone marrow lasts at least 4 years and further advances in treatment in subsequent years of clinical evaluation are not ruled out.
7. Is there a possibility of side effects occurring directly or in the long term after the implementation of the therapy?
In the control studies of patients which have been conducting for four years since the implementation of therapy, up to the date no side effects were observed.
The transfer of stem cells takes place in an autologous system, which means that the same patient is the donor and recipient of the biological material. This allows to avoid the risk associated not only with the graft-versus-host reaction, but also the transmission of viral, bacterial and parasitic diseases. The risk associated with infection of the biological material marrow, and stem cells isolated from it, practically does not occur due to the assurance of sterility conditions and high quality control standards throughout the entire process. The biological material is subjected to several stages of biological infection control, both in the Luna Laboratory medical-scientific center as well as in an external microbiological analysis laboratory.
8. How long does it take and how is the autologous transfer of stem cells?
Autologous stem cell transfer is a two-day standard procedure. On the first day until noon the bone marrow is taken. The collection takes place under local anesthesia and lasts approx. 2 hours.
On the second day in the early afternoon, the patient comes back to the medical center for an intravenous administration of a medicine composed of his own stem cells. The medicine is given via a drip, after which the patient remains under medical care in the clinic until the next morning.
9. How does the preparation of an autologous medicine in the laboratory take place?
Preparing stem cells for autologous transplantation is a highly specialized technology. The works take place in the clean room, it is space with controlled conditions of cleanliness. In addition to the microbiological control of the premises, we control the entire production process of the medicinal product. At each stage, the works are carried out in strictly defined procedures. As a result of the unique cell separation technology developed by Luna Laboratory, the patient is given only the most "beneficial" non-hematopoietic stem cells.
The risk associated with infection of the biological material marrow, and stem cells isolated from it, practically does not occur due to the assurance of sterility conditions and high quality control standards throughout the entire process. The biological material is subjected to several stages of biological infection control, both in the Luna Laboratory medical-scientific center as well as in an external microbiological analysis laboratory.
10. Who is the doctor conducting the therapy and what is the medical experience? What qualifications do physicians who carry out bone marrow picking have?
The neurologist is qualified for the patient's therapy, and then the patient is consulted by a surgeon and anesthesiologist. Bone marrow retrieval is performed by a surgeon-orthopedic physician. After the collection, the patient remains under the care of a nurse. The finished medicine is administered under the constant supervision of a nurse.
11. Where is the procedure performed?
Taking the bone marrow and giving the patient the autologous preparation takes place in a specialist clinic.
12. Will observation of treatment effects be conducted after the Luna Laboratory treatment?
After completion of hospitalization, the patient appears in the medical center at the control visit after about 3 months to assess his health and the therapeutic effects of the cell treatment.
13. How can I qualify for therapy?
Contact us personally at tel. +48 609 557 775 or by e-mail: biuro@lunalab.pl
