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The therapy used by PolTREG is autologous. The blood donor and the recipient of the finished product are the same person.
The cells are not subjected to genetic manipulation, only the number of cells – naturally low or with lower activity in patients with type 1 diabetes – is multiplied under laboratory conditions, before being transfused back to the patient.
We have experience in treating more than 100 patients. We have performed the first administration of TREGs in humans.
The world’s first administration of T-regulatory cells to a patient
We have over 17 years of experience
in the use of T-regulatory cells in the treatment of autoimmune diseases.
The therapy of type 1 diabetes
has been used in patients for many years through the hospital exemption procedure.
Effectiveness of our therapy
The clinical trials conducted so far have demonstrated promising safety and effectiveness of our therapy.
PolTREG treatment regimen
in 4 steps
TREG cells isolation from blood
Ex vivo multiplication of TREG cells
Implementation of the TREG preparation to the patient
Information regarding the treatment with TREG lymphocytes Therapy for recent-onset type 1 diabetes is currently offered ONLY by the Department of Paediatrics, Diabetology and Endocrinology of the University Clinical Center in Gdańsk.
Medical, formal and financial requirements for recruitment to TREGs lymphocyte treatment at the University Clinical Centre in Gdansk, Poland – Read more
- Information clause of PolTREG S.A. for parents/legal guardians
- Statement about reading the information clause of poltreg s.a. for parents/legal guardians
- Statement about reading the information clause of poltreg s.a. for parents/legal guardians (over 13 years of age)
- Statement concerning consent to processing personal data of the child/parent/legal guardian
- Statement concerning consent to processing personal data of the child/parent/legal guardian (over 13 years of age)
Information on preliminary recruitment criteria for patients with newly diagnosed type 1 diabetes mellitus for cell therapy of type 1 diabetes based on artificially multiplied CD4+CD25+CD127 regulatory T cells (TREGs therapy).
Immune therapy using T-regulatory lymphocytes is designed to inhibit the autoimmune process and thus to slow down the development of type 1 diabetes by prolonging the period of insulin secretion and remission of diabetes. Its aim is to alleviate and slow down the natural course of the disease.
Preliminary criteria on the basis of which the patient can undergo qualification tests at the Department of Paediatrics, Diabetology and Endocrinology of the University Clinical Center in Gdańsk:
- Age 3-16 years (final decision made by the treating clinician)
- BMI between the 25th and 75th percentile on the BMI percentile grid, or in the OLAF calculator (final decision made by the treating clinician)
- Early phase of type 1 diabetes – optimally prediabetes status or the first 4 months of the disease
- Fasting C-peptide level at diagnosis of diabetes > 0.7 ng / ml – tested at glycemia not higher than 130 mg / dl and maintained at least at this level until qualification (current fasting C-peptide result with fasting glucose may be required – taken at the same time)
- Confirmed autoimmune background of type 1 diabetes, i.e. positive titre of autoantibodies confirming the destruction of pancreatic beta cells (anti-GAD – against glutamic acid decarboxylase, ICA – anti-islet, IAA – anti-insulin, anti-ZnT8-against zinc transporter, anti-IA2 – antityrosine)
- Total insulin requirement < 0.5 U/kg body weight/day (optimally <0.3U/kg body weight/day) and no clear trend towards increasing insulin therapy
- Balanced daily glycemic profile
- Not taking other drugs besides insulin permanently (does not apply to vitamin D, thyroid hormones, antiallergic drugs, drugs used topically, e.g. inhalation, on the skin)
- Absence of comorbidities and past diseases, in particular:
– disorders of the hematopoietic system (anemia, lymphopenia, neutropenia, thrombocytopenia)
– cancer (current or past)
– thrombosis (current or past)
– hypertension (verified in OLAF calculator)
– micro- or macroalbuminuria (based on the result of daily urine collection with assessment of albumin excretion or UACR test from the morning portion of urine)
– retinopathy (based on the result of an ophthalmological examination with fundus assessment)
– IgA deficiency and other immune deficiencies
– systemic fungal infections, active inflammatory foci in the body, e.g. tooth decay (based on a certificate from a dentist), chronic inflammation, e.g. of the paranasal sinuses, recurrent bacterial, viral or fungal infections difficult to treat
– active EBV infection (negative anti-EBV antibodies in the IgM class)
– previous or active infection with HIV, HCV, HBV, tuberculosis bacillus, syphilis spirochete
- Having a set of vaccinations in accordance with the Preventive Vaccination Program in force in Poland (based on the certificate from a pediatrician at POZ)
- In the case of pigmented nevi on the skin, in particular numerous >0.5 cm, atypical or of oncological concern – having a certificate from a dermatologist with a dermatoscopic assessment of nevi
- Proper adherence to the principles of self-control of diabetes, in particular the principles of healthy eating, regular glucose monitoring, insulin dosage adapted to the body’s needs, regular physical activity
- The ability of the patient and the child’s parents/guardians to treat diabetes in accordance with the accepted standards of the Polish Diabetes Association in the field of self-control of diabetes and insulin therapy. Good level of education in this area. Good cooperation with medical staff and adherence to the recommendations issued
- In the case of already introduced insulin therapy, the use of insulin analogues (non-NPH and short-acting insulins)
- Lack of difficulties in collecting venous blood, including significant needle phobia of the child (the possibility of collecting under general anesthesia – in this case the necessary lack of contraindications to anesthesia)
- Lack of emotional and mental disorders in the child and parents/caregivers (e.g. depressive disorders, eating disorders, lack of acceptance of the disease, lack of motivation for treatment, presence of addictions, etc.) hindering the treatment of diabetes and cooperation with the therapeutic team
- The ability of the child’s parents or guardians (as well as the child if s/he is over 13 years of age at the time of the examination) to sign an informed consent before starting the therapy
The therapy should only be started in patients who are willing to collaborate with the therapeutic team. The final decisions regarding the suitability of patients for TREGs therapy are made by the therapeutic team, taking into account the complete clinical picture and the assessment of the prognosis for response to therapy.
TREG therapy involves the following steps: extracting blood from the patient, isolating TREGs (regulatory T cells) from the blood sample, multiplying these cells in the laboratory without altering their properties (from 0.5 million to 2-4 billion cells within 10 days), and finally administering the multiplied TREGs back to the patient. PolTREG is a global leader in this therapy, having accomplished several milestones. It conducted the first-ever human administration of TREGs. Furthermore, the company’s clinical development of TREG-based therapy for recent-onset type 1 diabetes in children and adolescents is one of the most advanced programs known to the company.
TREG therapy can be used in children aged 3-16 years and in adults.
Clinical trials conducted by the Company so far confirm the acceptable safety of TREGs therapy.
To date, PolTREG has conducted clinical trials and administered treatments under the hospital exemption program. No serious side effects have been observed during these trials and treatments.
Yes. The therapy is conducted at the University Clinical Center in Gdańsk under the hospital exemption program, with comprehensive support from hospital facilities. Additionally, there is a laboratory that adheres to the highest standards of purity following the GMP (Good Manufacturing Practices) guidelines.
Under the hospital exemption program and as part of the clinical trials the TREGs treatment was administered to more than 100 patients with recent-onset type 1 diabetes.
Insulin does not cure diabetes, but only regulates the amount of glucose in the blood. TREGs therapy, on the other hand, has been shown to slow the progress of type 1 diabetes. The primary benefit of TREGs therapy is its potential ability to preserve partial insulin secretion by the pancreas. This enables better control of blood sugar levels, allowing for quicker response to changes and reducing the risk of complications associated with high blood sugar spikes. TREGs therapy has also been shown to reduce the risk of comorbidities such as thyroid disease or celiac disease.
No. TREGs therapy differs from transplants by utilizing isolated, purified, and occasionally modified cells obtained from the patient’s blood, rather than whole organs or tissues.