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Autologous Dendritic Cell Therapy for Type 1 Diabetes Suppression: A Safety Study
Bu çalışmada, hastanın kendi kanından elde edilen dendritik hücrelerin (bağışıklık sistemini yönlendiren hücreler) laboratuvarda CD40, CD80 ve CD86 moleküllerini hedefleyen antisens oligonükleotitlerle işlenmesiyle hazırlanan bir hücre aşısı denenmiştir. Amaç, bu bağışıklık düzenleyici dendritik hücrelerin (iDC) yerleşmiş tip 1 diyabeti olan kişilerde güvenli olup olmadığını görmektir. Faz 1 (Phase 1) çalışmaya, insülin tedavisi alan ve diyabete bağlı komplikasyonu bulunmayan 15 yetişkin katılmış; bir bölümüne kontrol hücreleri, bir bölümüne iDC uygulanmıştır.
Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.
Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.
Inclusion Criteria:
Patients with established type 1 diabetes mellitus who meet all inclusion criteria are eligible for enrollment in the study.
* All patients enrolled must be on insulin replacement therapy.
* Written informed consent conforming to the institutional guidelines obtained from the patient.
* Documented evidence of insulin-requiring type 1 diabetes of \>5 years duration.
* Adequate immune competence, as indicated by positive reaction to one or more of the common DTH skin tests that are part of the Multitest CMITM test system (Pasteur-Merieux Connaught) and as indicated by the manufacturer. Also, proof of vaccination for tetanus (no more than 10 years must have elapsed between tetanus vaccination and the onset of this study).
* Age 18-35.
* Adequate hematologic function:
* Absolute neutrophil count \> 1,000/mm3
* Absolute lymphocyte count \> 1,000/mm3
* Hemoglobin \> 9 gm/dl
* Platelets \> 100,000/mm3
* Liver function tests:
* Bilirubin (total) \< 1.7 mg/dl
* Alkaline phosphatase \< 78 u/L (2 x ULN)
* SGOT \< 54 u/L (2 x ULN)
* Lactic dehydrogenase \< 180 u/L (2 x ULN)
* Kidney profile:
* Serum electrolytes
* Sodium 135-145 mEq/L
* Potassium 3.5-5.0 mEq/L
* Bicarbonate 21-28 mEq/L
* Chloride 100-108 mmol/L
* Serum creatinine \<4.5 mg/dL (3 x ULN)
* BUN 8-25 mg/dL
* No prior history of radiation therapy, immunotherapy, or chemotherapy
* Evidence of prior immunization to tetanus
* Absence of HIV, HSV, HBV, HCV viral infections
* At least four weeks since any prior radiation , immunotherapy or chemotherapy
Exclusion Criteria:
* One or more of the Eligibility Criteria are not met.
* A significant history or current evidence of cardiac disease including, but not limited to, congestive heart failure, coronary artery disease, angina pectoris, uncontrolled hypertension, serious arrhythmias; or myocardial infarction within the previous six months.
* Evidence of active infection requiring antibiotic therapy.
* History of other concurrent diseases.
* Pregnant or lactating women.
* Patients requiring systemic corticosteroids
* Any other immune disorder including but not limited to other autoimmune diseases like rheumatoid arthritis, systemic lupus erythematous, multiple sclerosis, or ankylosing spondylitis
* Pregnancy
* History of radiation therapy, immunotherapy, or chemotherapy
* Breastfeeding
* The following therapies cannot be administered while patients are undergoing treatment on this protocol:
* radiation therapy
* chemotherapy
* corticosteroids (except when administered in life-threatening circumstances) other particle or cell vaccine therapies
At the time of screening, the patients will be tested for evidence of the following viral infections: HIV, HBV, HCV, herpes, CMV and EBV. In addition, female volunteers will be asked to provide documentation from their physician stating that they have not tested positive for the HPV viral infection. Only patients testing negative for ALL these viral infections will be further considered. Should any volunteer be excluded on grounds of positivity for any of these infectious agents, they will be immediately notified and strongly advised to consult their physician. The data and the records will be maintained under lock and in the study participation file of the volunteer until the volunteer confirms in writing that they have notified their physician. At that time, these specific data may be submitted to the patient's physician ONLY DIRECTLY BY THE VOLUNTEER upon written request to the study principal investigator or immediately destroyed.