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Boost to Brittle Bones - Stem Cell Transplantation for Treatment of Brittle Bones

NCT04623606 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2020-11-10

No results posted yet for this study

Summary

An exploratory, open label, multiple dose, phase I/II trial (n=15) evaluating safety and efficacy of intravenous and intraosseous infusion of allogeneic expanded fetal mesenchymal stem cells (MSC) for the treatment of severe Osteogenesis Imperfecta (OI) compared with historical and untreated prospective controls.

Conditions

Interventions

BIOLOGICAL

BOOST cells

Four doses of expanded human 1st trimester fetal liver-derived mesenchymal stem cells.

Sponsors & Collaborators

  • Ministry of Science and Technology, India

    collaborator OTHER_GOV

  • Vinnova

    collaborator OTHER_GOV

  • Karolinska Institutet

    collaborator OTHER

  • Christian Medical College, Vellore, India

    lead OTHER

Principal Investigators

  • Vrisha Madhuri, MS Orth · Christian Medical College, Vellore, India

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
8 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-20
Primary Completion
2021-11-30
Completion
2021-12-31

Countries

  • India

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04623606 on ClinicalTrials.gov