Trials / Unknown
UnknownNCT04623606
Boost to Brittle Bones - Stem Cell Transplantation for Treatment of Brittle Bones
Exploratory, Open Label, Multiple Dose, Phase I/II Trial Evaluating Safety, Efficacy of Intravenous and Intraosseous Infusion of Allogeneic Fetal Mesenchymal Stem In Treatment of Severe Osteogenesis Imperfecta Compared With Historical and Untreated Prospective Controls
- Status
- Unknown
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 15 (estimated)
- Sponsor
- Christian Medical College, Vellore, India · Academic / Other
- Sex
- All
- Age
- 1 Year – 8 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | BOOST cells | Four doses of expanded human 1st trimester fetal liver-derived mesenchymal stem cells. |
Timeline
- Start date
- 2019-05-20
- Primary completion
- 2021-11-01
- Completion
- 2021-12-01
- First posted
- 2020-11-10
- Last updated
- 2020-11-10
Locations
1 site across 1 country: India
Source: ClinicalTrials.gov record NCT04623606. Inclusion in this directory is not an endorsement.