A study to evaluate the effectiveness and safety of allogeneic fetal bone tissue-derived mesenchymal stem cell therapy to develop a cell therapy for the rare and incurable disease osteogenesis imperfecta

A single-institution researcher-led clinical study to evaluate the efficacy and safety of allogeneic Ectopic Embryonic Calvaria-derived Mesenchymal Stem Cell therapy for the treatment of a rare intractable disease, osteogenesis imperfecta

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0010392

Enrollment

Registered

2025-04-08

Start date

2025-11-05

Completion date

Unknown

Last updated

2026-01-05

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

Conditions

None listed

Interventions

Biological/Vaccine, Stem Cell : 1) Name: Ectopic Embryonic Calvaria-derived Mesenchymal Stem Cell, EE-cMSC 2) dosage: 4X 1,000,000 Cells/kg 3) Number of doses :Once 4) Route: Intravenous

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Children diagnosed with osteogenesis imperfecta 2. Men and women, under 17 years of age

Exclusion criteria

Exclusion criteria: 1. Persons with severe cardiopulmonary dysfunction who rely on supplemental oxygen 2. Those with infectious diseases 3. Those registered in other research and clinical trials 4. Other people deemed unsuitable by the research director

Design outcomes

Primary

Measure	Time frame
Adverse Event	—

Secondary

Measure	Time frame
Bone mineral density (BMD);growth (height, weight);clinical laboratory tests (hematological, serum biochemical, coagulation, bone formation/resorption markers, and urinalysis);X-rays (spine, arms, legs);a questionnaire (SF-36)	—

Countries

Korea, Republic of

Contacts

Public ContactYoungSoon Ahn

Bundang CHA General Hospital

a210387@chamc.co.kr+82-31-780-4979

Outcome results