In a one year pilot phase the essential infrastructure for the implementation of the Human Gene Transfer Clinical Trials database has been setup in co-operation with the "Commission of Somatic Genetransfer" (KSG) and the "German Working Group for Genetherapie" (DAG-GT).
The next step will be to design a database structure which will serve the needs of different users. The first data collected during pilot phase is presented in an aggregated form: see diagrams. The current status of registered trials is being updated and will be published stating all relevant study details in the databases second phase.

The diagramms are based on all studies, that are voted 'positive', 'no rooted objections', 'on hold' or 'conducted without vote by KSG', and whose trial-status is either 'initiated', 'cancelled after initiation', 'suspended' or 'finished according to protocoll'.
That includes all trials, that were not voted negative by the KSG-Kommission and have been initiated at least for some time. Only the diagramm 'number of patients' is based on all trials, where patients have been treated.

Target Disease

Disease subcategory

Human immunodeficiency virus [HIV]6
Malignant neoplasm of other and ill-defined sites in the lip, oral cavity and pharynx 4
Malignant melanoma of skin 3
Malignant neoplasm of pancreas 3
Malignant neoplasm of spinal cord, cranial nerves and other parts of central nervous system 3
Chronic ischaemic heart disease 2
Malignant neoplasm of bronchus and lung 2
Malignant neoplasm without specification of site2
Myeloid leukaemia 2
Peripheral vascular diseases2
Malignant neoplasm of ovary2
Malignant neoplasm of kidney, except renal pelvis 2
Functional disorders of polymorphonuclear neutrophils 1
Transplanted organ and tissue status 1
Malignant neoplasm of prostate1
Mesothelioma1
Malignant neoplasm of bladder1
Malignant neoplasm of breast1

Strategy

Study Phases

Study Characteristics

Number of centres monocentric 15 multicentric 24     n.a. 0
Centre location national 23 international 15     n.a. 1
Randomization not randomized 28 randomized 10     n.a. 1
Blinding not blinded 33 blinded 2 double blinded 3 n.a. 1
Viral transfer-system in vivo 21 ex vivo 7 not appropriate 10 n.a. 1
Nonviral transfer-system in vivo 4 ex vivo 6 not appropriate 28 n.a. 1

Therapeutic Strategy

Trial Status

Number of patients treated in clinical trials