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Evaluate the Safety and Therapeutic Effects of a Single Intravenous Infusion (IV) of Autologous CD34+ Cells Enriched With Allogenic Placenta-derived Mitochondria in Patients With a Diagnosis of Pearson Syndrome (PS)

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later Dec 2026 → Dec 2027
See other at-risk trials from Minovia Therapeutics Ltd.

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Dec 2026 to Dec 2027
    • Study completion pushed from Dec 2027 to Dec 2028
    • Eligibility criteria expanded, about 22 words
    • Secondary endpoints: details revised at 1 of 2 entries
  2. Phase: Phase 1 to Phase 2v5 Show 6 more changesShow less
    • Primary endpoints: 1 to 2
    • Enrollment target: 5 to 6
    • Eligibility criteria expanded, about 118 words
    • Secondary endpoints: 7 to 2
    • Site details revised
    • Study title expanded, about 14 words
  3. Secondary endpoints: details revised at 1 of 7 entriesv4
  4. Secondary endpoints: 6 to 7
    • Eligibility criteria shortened, about 5 words
    v3
  5. Primary endpoint revised
    • Secondary endpoints: 3 to 6
    • Study title shortened, about 4 words
    v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Primary Mitochondrial diseases are a clinically and genetically heterogeneous group of disorders caused by mutations in genes encoded by nuclear Deoxyribonucleic Acid (DNA) or by mutations and/or deletions in the mitochondrial DNA (mtDNA). While some mitochondrial disorders only affect a single organ (e.g., the eye in Leber hereditary optic neuropathy \[LHON\]), many involve multiple organs. Mitochondrial disorders may present at any age and a frequent feature is the increasing number of organs involved in the course of the disease. Minovia Therapeutics Ltd. ("Minovia") is a biotech company developing novel therapeutics based on its mitochondrial augmentation technology (MAT). MNV-201 is a cell therapy produced by MAT that consists of the participant's autologous CD34+ hematopoietic stem and progenitor cells (HSPCs) enriched with allogeneic placental-derived mitochondria, manufactured in Minovia's GMP facility.
Trial Details
NCT Number NCT06017869
Lead Sponsor Minovia Therapeutics Ltd.
Conditions
(from sponsor)		 Mitochondrial Diseases, Pearson Syndrome
Related terms Mitochondrial Diseases, VLCAD deficiency
Enrollment 6 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov