Court gives hope to controversial stem-cell therapy
(By Sandra Cordon) (ANSA) – Rome, December 4 – Italy’s health ministry, under pressure from advocates and the courts, said Wednesday that it will appoint a new panel of experts to assess its protocols governing the use of controversial stem cell treatments for the desperately ill, including small children.
The announcement came shortly after the Lazio Regional Administrative Court suspended a previous federal panel, upholding an appeal from David Vannoni, president of Italy’s Stamina Foundation which supports the stem-cell treatment that critics say has been untested and could be dangerous.
In their order the judges, who have set June 11 for a review of the matter, urged the health ministry to conduct a serious investigation of the so-called Stamina treatment. The health ministry and the scientific community should give priority to a full investigation “so thorough as to leave no more room for doubt,” the judges said.
Health Minister Beatrice Lorenzin echoed that, saying the new committee must act quickly “because I believe that in this matter no one can leave patients and families in doubt”.
She said the new committee would be appointed very quickly and include foreign experts.
The first expert panel that the Italian government appointed had been asked to come up with a trial design for the therapy.
However, it concluded in September that the Stamina treatment has no scientific foundation and that there was no point in doing the wider study, for which the Italian government had allocated three million euros. The Stamina Foundation challenged that finding before the Lazio regional court, arguing that the composition of the healthy ministry’s commission had been flawed because the experts were not impartial.
It said that some members of the commission had expressed opposition to Stamina treatment before the commission’s work even began. Stamina therapy involves extracting bone marrow stem cells from the patient, turning them into neurons by exposing them to retinoic acid for two hours, and injecting them back into the patient.
Supporters of the therapy say it could be a cure for fatal degenerative nerve diseases while detractors say it is devoid of scientific merit.
The therapy has been a hot topic in the media and in the courts, and protestors have rallied to draw attention to their cause, including a major march in late November in central Rome.
Pope Francis also boosted interest in the issue and gave it a very human face when he met with the family of toddler Noemi Sciaretta and prayed for the little girl.
Late last month, a judge rejected an appeal for access to the therapy for the 18-month-old Noemi who is suffering from spinal muscular atrophy (SMA), a hereditary, muscle-wasting disease with no known cure and the most common genetic cause of infant death.
The parents of Noemi, who had been admitted to hospital in critical condition late last month, had already been turned down by two other judges in their quest to have their daughter admitted to a clinical trial of the Stamina treatment. The regional judges also said Wednesday that the first committee should have examined the medical records of patients who had been through the Stamina treatment in hospital in Brescia, a northern city where the procedure had been used. The judges noted that records from that hospital do not show any adverse effects experiences by patients there from the Stamina treatment.
Andrea Sciarretta, the 26-year-old father of baby Noemi, said that the new panel’s appointment was “very good news” but added he was still frustrated that her treatment has been delayed.
“When Naomi felt ill (in late November) I thought all was lost,” he said by telephone.
“I prayed so much. I turned to Jesus because my strength was leaving, and then I looked at my daughter and I started to fight,” said Sciarretta.