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OPEN-LABEL, PHASE I CLINICAL TRIAL TO EVALUATE THE SAFETY AND PRELIMINARY CLINICAL RESPONSE TO THE USE OF ALLOGENEIC BONE MARROW MESENCHYMAL STEM CELLS IN CHILDREN AND ADOLESCENTS WITH X-LINKED ADRENOLEUKODYSTROPHY CEREBRAL FORM.

Status
Not yet recruiting
Phases
Phase 1
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2026-526701-14-00
Enrollment
5
Registered
2026-10-13
Start date
Unknown
Completion date
Unknown
Last updated
2026-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adrenoleukodystrophy

Brief summary

Safety assessment: Dose-limiting toxicities (DLTs, defined in the protocol as grade 3 toxicities according to NCI-CTCAE V5.0 (Common Terminology Criteria for Adverse Events version 5.0) will be measured (severe toxicity or medically significant but not immediately fatal; hospitalisation or prolongation of indicated hospitalisation; disabling; limits self-care and basic activities of daily living of the patient) related to MSC infusion occurring in the first 28 days of treatment).

Interventions

DRUGBone marrow-derived Mesenchymal Stromal Cells cryopreserved at passage P2
DRUGthawed
DRUGwashed and syringe-conditioned in 0.9% NaCl - 0.5% human serum albumin injection solution at a dose of 5.10^6 Mesenchymal Stromal Cells

Sponsors

Fundacion Para La Investigacion Biomedica Hospital Infantil Universitario Nino Jesus
Lead SponsorOTHER

Eligibility

Sex/Gender
Male
Age
0 Years to 17 Years

Design outcomes

Primary

MeasureTime frame
Safety assessment: Dose-limiting toxicities (DLTs, defined in the protocol as grade 3 toxicities according to NCI-CTCAE V5.0 (Common Terminology Criteria for Adverse Events version 5.0) will be measured (severe toxicity or medically significant but not immediately fatal; hospitalisation or prolongation of indicated hospitalisation; disabling; limits self-care and basic activities of daily living of the patient) related to MSC infusion occurring in the first 28 days of treatment).—

Outcome results

None listed

Source: EU CTIS · Data processed: Oct 14, 2026