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Subcutaneous Injection of Sodium Thiosulfate for Ectopic Calcifications or Ossifications. A Pilot Study

RecruitingPhase 2Ages 6 Months - anyAllUniversity Hospital, Limoges
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In plain words

What the trial is, and whether it could suit you

Ectopic soft tissue calcifications or ossifications can complicate the course of numerous diseases; most of them are rare or very rare. Even if the clinical, radiological and pathological presentation of ectopic calcifications and ossifications are different, the same hypotheses are discussed considering their hypothetical pathophysiology. Indeed, high calcium phosphate product, local cellular lesions and abnormal transdifferentiation of mesenchymal cells are regularly evoked when pathophysiology of such calcifications or ossifications are discussed. Apart from several case reports that have not been confirmed so far, no medical treatments are available, leading to significant pain and impairment of quality of life for patients. Therefore, only surgical treatment can be proposed when the volume or the consequences of these calcifications/ossifications become too important. Sodium thiosu

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📋 Eligibility rules (as published)
Inclusion Criteria: * Patient presenting with: * ectopic ossification secondary to iPPSD2 or * ectopic calcification secondary to dermatomyositis or * ectopic calcification secondary to systemic sclerosis * Patient aged 2 years or over * Indication of STS infusion validated by a multidisciplinary committee, based on the significant morbidity and/or functional impact of the targeted calcification/ossification * Patient with no planned surgery of the calcifications/ossifications for the twelve coming months * Women of childbearing potential on highly effective contraception (such as hormonal contraception, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomised partner or sexual abstinence) * Men with women of childbearing potential partners should use condoms during the whole treatment period and until 91 days after the last injection. * Informed consent signed by the patient / parents * Patient affiliated to the social security system Exclusion Criteria: * Allergy to STS or one of the excipients used * Contraindication to local injection of STS * Anticoagulant therapy * Pregnant, parturient or breastfeeding woman * Patient deprived of freedom by a court judgment or an administrative decision * Patient undergoing psychiatric care under coercion * Legally protected adult patients (guardianship / curatorship) * Patient unable to give consent * Patient placed under judicial protection
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What it tests

  • STS
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Where

11 sites
CHU de BORDEAUX
Bordeaux, France
Hospice Civil de Lyon
Bron, France
ApHp - Hôpital Bicêtre
Le Kremlin-Bicêtre, France
CHU de Limoges
Limoges, France
ApHp - hôpital Lariboisière
Paris, France
Hôpital Cochin
Paris, France
Hôpital de la Pitié Salpétriêre
Paris, France
CHU de RENNES
Rennes, France

…and 3 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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