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NCT05559801NOT_YET_RECRUITINGanonymous

A Phase 1/2 Study to Examine the Safety and Preliminary Efficacy of Mesenchymal Stromal Cells on Linear Growth and Bone Health Parameters in Children With Type 3 Osteogenesis Imperfecta (OI)

Sponsor

Source record

Emory University

Phase

Source record

PHASE1

Modality

AI-normalized

gene therapy

Target

AI-normalized

Bone marrow-derived mesenchymal stromal cells (MSCs)

Indication / condition

AI-normalized

Osteogenesis Imperfecta

Intervention

Source record

Bone marrow-derived mesenchymal stromal cells (MSCs)

Source & freshness

Source record

NCT ID

NCT05559801

Original source

ClinicalTrials.gov

Source last updated

May 08, 2026

Ingested at

Jun 11, 2026

Internal sync

Jun 11, 2026

Model version

trialsignal-ai-v1

Normalized confidence

96%

Validation status

validated

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View original source fields

NCT ID

NCT05559801

Title

A Phase 1/2 Study to Examine the Safety and Preliminary Efficacy of Mesenchymal Stromal Cells on Linear Growth and Bone Health Parameters in Children With Type 3 Osteogenesis Imperfecta (OI)

Sponsor

Emory University

Status

NOT_YET_RECRUITING

Phase

PHASE1

Condition raw

Osteogenesis Imperfecta, Osteogenesis Imperfecta Type III

Condition normalized

Osteogenesis Imperfecta, Osteogenesis Imperfecta Type III

Modality raw

gene therapy

Modality normalized

gene therapy

Target raw

Bone marrow-derived mesenchymal stromal cells (MSCs)

Target normalized

Bone marrow-derived mesenchymal stromal cells (MSCs)

Interventions

Bone marrow-derived mesenchymal stromal cells (MSCs)

Public preview

Source record

This is a Phase 1/2 study to determine the safety and efficacy of allogeneic (third party), bone-marrow derived mesenchymal stromal cells (MSCs) for the treatment of Osteogenesis Imperfecta (OI) Type 3. It will evaluate this by looking at whether there are treatment related infusion reactions, and assessing linear growth rates and bone health, both of which are impaired in patients ages 3-10 with Osteogenesis Imperfecta Type 3. This is a single-site non-randomized clinical trial, that will take place at Children's Healthcare of Atlanta (CHOA) at Egleston and Emory Children's Center.

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