Compassionate Treatment

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What is compassionate treatment? It originates from humanitarian laws.

The term "Compassionate Treatment" in English means showing sympathy and mercy.

"Compassionate Treatment", simply put, is a treatment aimed at severely ill patients, using therapies that have not yet been officially approved by the regulatory authorities.。

In April 2016, the Ministry of Health and Welfare officially renamed "Compassionate Treatment" to the "Regulations on Human Trials" and partially opened the application conditions for subsidiary proposals. This regulation was established earlier than the "Administrative Regulation on Special Medical Instruments and Inspection Techniques" and the "Draft Act on Regenerative Medicine and Regenerative Medicinal Products".
Article 3-1 of the Regulations on Human Trials: For the treatment of specific patients with life-threatening diseases or serious disabilities for which no effective drugs, medical devices, or medical technologies are available in Taiwan, a medical care institution may draft a subsidiary proposal for a human cell therapy trial that has been approved by the central competent authority and has accumulated a considerable amount of safety data, and may submit the same, together with a photocopy of the original human trial proposal approved, for review in accordance with Paragraph 3 of Article 78 of this Act. After approval by the Review Board, the institution may apply to the central competent authority for approval of using the drugs, medical devices, or medical technologies involved on patients who meet the indications but fail to meet the eligibility criteria for original human trial subjects.

Conditions for Applying for Compassionate Treatment

Lukas Biomedical is dedicated to cancer cell therapy and offers immunocellular therapy under the provisions of Article 3-1 of the "Regulations on Human Trials". Currently, applications for 'Compassionate Treatment' are only open to professional physicians. If you have an urgent need and meet the following conditions, please discuss them in detail with your doctor.

The treatment can only be carried out if the following conditions for the physician, patient, and cell preparation manufacturer are met:

👨＜Patient＞：The patient has a critical or major illness with no alternative treatments available domestically, or has not responded to all available treatments, or has relapsed, or has contraindications to treatment.

👨‍🔬＜Physician＞：The drugs or medical devices used in compassionate treatment must have clinical trial results demonstrating efficacy and safety. The application must be submitted by the patient's attending physician, and the indication for which the application is made must be the same as that for which the clinical trial was conducted.

💉＜Technology＞：The manufacturer agrees to provide the drugs or medical devices.

Patients in need must be evaluated and diagnosed by a specialist physician at a hospital approved by the Ministry of Health and Welfare before the treatment can be carried out. Do not trust unverified sources claiming to offer cell therapy!