Dutch authorities ban Rotterdam stem cell treatment
09 Oct 2006
The Dutch health care inspectorate has ordered the PMC clinic in Rotterdam to stop performing stem cell treatments for MS and other conditions.
In a statement it said it had concluded PMC was not providing responsible care, because it is unable to demonstrate the origin, suitability and safety of the stem cells it used. This jeopardised the health and safety of patients. Among other things, it exposed patients to the risk of infection with HIV or Creutzfeldt-Jacob Disease, allergic reactions, malignant tumours or rejection reactions.
On Friday 29 September, the Inspectorate received a notification from the Havenziekenhuis hospital in Rotterdam about a patient who had to be admitted with serious complications following stem cell treatment at the clinic. The patient had a serious acute allergic reaction after the administering of stem cells. After being treated, the patient was allowed to return home.
Said the Inspectorate: “Under the Dutch Care Institutions (Quality) Act, the PMC is required to provide responsible care. This means care of a good level that is efficient, effective and suitable for the patient. In the case of stem cell treatment, the PMC is obliged to demonstrate through documentation the safety of the entire stem cell supply chain from donor to recipient. To date, the PMC has been unable to present any documentation to the Inspectorate concerning the origin, the suitability for the intended application and the safety of the products that are used.”
The weeklong-order took effect at 5pm on Monday 2 October and the Inspectorate is expected to ask the Minister of Health, Welfare and Sport to renew it. The Inspectorate said it was also considering bringing disciplinary charges against the physicians who work at the PMC.
Said the Inspectorate: “Under the Dutch Care Institutions (Quality) Act, the PMC is required to provide responsible care. This means care of a good level that is efficient, effective and suitable for the patient. In the case of stem cell treatment, the PMC is obliged to demonstrate through documentation the safety of the entire stem cell supply chain from donor to recipient. To date, the PMC has been unable to present any documentation to the Inspectorate concerning the origin, the suitability for the intended application and the safety of the products that are used.”
The weeklong-order took effect at 5pm on Monday 2 October and the Inspectorate is expected to ask the Minister of Health, Welfare and Sport to renew it. The Inspectorate said it was also considering bringing disciplinary charges against the physicians who work at the PMC.
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