The manufacture of TREG preparation begins with the collection of a venous blood sample of the patient under the care of the treating physician.
Treatment is carried out according to the following schedule:
The therapy is autologous, so the donor of blood and recipient of the finished product is one and the same person. Cells are not subjected to genetic manipulation, only their quantity – naturally low or less active in patients with type 1 diabetes – is multiplied under laboratory conditions, before being re-transfused.
The therapy is conducted at the University Clinical Centre in Gdańsk in the “Hospital Exemption” model, with full support of the hospital facilities with the highest purity laboratory in compliance with the GMP standard.
Information on treatment options with TREG lymphocytes
Type 1 diabetes therapy is currently offered ONLY by the Clinic for Paediatry, Diabetology and Endocrinology of the University Clinical Centre in Gdańsk.
Information on the initial criteria for recruiting patients with newly diagnosed type 1 diabetes to cell therapy of type 1 diabetes based on artificially expanded CD4 + CD25 + CD127– regulatory T cells (Tregs therapy)
Immune therapy with the use of T-regulatory lymphocytes is intended to inhibit the autoimmune process and thus slowing down the development of type 1 diabetes by extending the period of insulin secretion and remission of diabetes. Its purpose is to alleviate and slow down the natural course of type 1 diabetes.
Initial criteria on the basis of which a patient may undergo qualification tests at the Department of Paediatrics, Diabetology and Endocrinology of the University Clinical Center in Gdańsk:
- age 3-16 (final decision made by the physician)
- BMI between the 25th and 75th percentile on the BMI percentile grid or in the OLAF calculator (final decision made by the physician) (http://olaf.czd.pl/index.php?option=com_content&view=article&id=103:kalkulator&catid=21:wyniki&Itemid=22)
- early stage of type 1 diabetes – optimal condition of prediabetes and the first 4 months of the disease
- fasting C-peptide level in the diagnosis of diabetes > 0.7 ng / ml – tested at blood glucose levels not higher than 130 mg / dl and maintained at, at least this level until qualification (current fasting C-peptide result with fasting glucose may be required – collected simultaneously)
- confirmed autoimmune background of type 1 diabetes, i.e. a positive titer of autoantibodies confirming the destruction of pancreatic beta cells (anti-GAD – anti-glutamic acid decarboxylase, ICA – anti-islet, IAA – anti-insulin, anti-ZnT8-against zinc transporter, anti-IA2 – anti-tyrosine)
- total insulin requirement <0.5 U / kg body weight / day (optimally <0.3 U / kg body weight / day) and no clear tendency to increase insulin requirement in the following weeks of insulin therapy
- a balanced daily glycemic profile
- not taking drugs other than insulin on a permanent basis (does not apply to vitamin D, thyroid hormones, antiallergic drugs, drugs applied topically, e.g. inhaled, on the skin)
- no comorbidities and past diseases, in particular:
- disorders of the hematopoietic system (anemia, lymphopenia, neutropenia, thrombocytopenia)
- cancers (current or past)
- thrombosis (current or past)
- hypertension (verified in the OLAF calculator)
- micro- or macroalbuminuria (having a result of a daily urine collection with an assessment of albumin excretion or UACR test from the morning portion of urine)
- retinopathy (having an eye examination with an eye fundus assessment)
- IgA deficiency and other immune deficiencies
- systemic fungal infections, active inflammatory foci in the body, e.g. tooth decay (requires a certificate from a dentist), chronic inflammation of e.g. paranasal sinuses, recurrent bacterial, viral or fungal infections difficult to treat
- active infection with EBV (negative anti-EBV IgM antibodies)
- past or active infection with HIV, HCV, HBV, mycobacterium tuberculosis, syphilis spirochete
- having a complete set of vaccinations in accordance with the Preventive Vaccination Program in force in Poland (certificate from the pediatrician of the POZ)
- in the case of pigmented moles on the skin, in particular numerous> 0.5 cm, atypical or causing oncological concern – a certificate from a dermatologist with a dermatoscopic assessment of moles
- proper adherence to the principles of self-control of diabetes, in particular the principles of healthy eating, regular glycemic monitoring, insulin dosing adjusted 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 diabetes self-control and insulin therapy. Sufficient level of education in this regard (to be assessed by interviewer). Good cooperation with medical personnel and compliance with the recommendations issued
- in the case of initiated insulin therapy, the use of insulin analogues (not NPH and short-acting insulins
- no difficulties in collecting venous blood, including significant needle phobia in a child (possible to collect under general anesthesia – in this case no contraindications to anesthesia are necessary).
- lack of emotional and mental disorders in both the child and the parents/guardians (e.g. depressive disorders, eating disorders, lack of acceptance of the disease, lack of motivation for treatment, presence of addictions, etc.) that make it difficult to treat diabetes and cooperate with the therapeutic team
- the ability to express informed consent by the parents or guardians of the child (as well as the child himself, if he or she turns 13 during the study)
Therapy can only be used in patients willing to cooperate. The final decision regarding the qualification of patients for Tregs therapy is made by the therapeutic team based on the entire clinical picture and assessment of the prognosis of response to the therapy.
Attention! The therapy requires financing from own resources (i.e. commercially).
- Qualification of the patient at the Department of Paediatrics, Diabetology and Endocrinology, UCK in Gdańsk – PLN 4,500
- Treatment with Tregs cells – consists of 2 doses of PLN 165,000 for each dose – a total of PLN 330,000 (the second dose of Tregs is administered after 3-5 months)
- Please prepare medical records from the period of diabetes diagnosis and get familiar with the test results, in particular those listed in the above criteria.
- Please read the following documents, print and send us the signed scans before submitting any personal information (i.e. your child’s medical records):
- Information clause for parents and legal guardians
- Statement of parents and guardians about reading the information clause
- Statement of parents and guardians about reading the information clause (applies to a child over 13 years of age)
- Consent of parents and guardians for data processing
- Consent of parents and guardians for data processing (applies to a child over 13 years of age)
Attention! Applications without signed consents for the processing of personal data cannot be considered.
Clinical Trial Director
tel. +48 731 471 845 open from 9am – 3pm (CET)
Detailed information on eligibility and treatment can be found at:
(click the TREGS THERAPY tab on the bottom of the page)