Loading clinical trials...

Boost to Brittle Bones - Stem Cell Transplantation for Treatment of Brittle Bones | Clinical Trials | Clareo Health

UNKNOWNPHASE1/PHASE2

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

NCT04623606•Christian Medical College, Vellore, India

View on ClinicalTrials.gov

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.

Eligibility

Age

1 - 8 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Parent's/legal guardian's signed informed-consent form
•2. Clinical diagnosis of OI type III or IV AND
•3. Molecular diagnosis of OI (Glycine substitution in the collagen triple-helix encoding region of either the COL1A1 or COL1A2 gene)
•4. Age between 1 to 4 years
•5. BP treatment initiated before inclusion
•6. Parent/legal guardian over 18 years of age
•1. Parent's/legal guardian's signed informed-consent form
•2. Clinical and molecular diagnosis of OI (Glycine substitution in the collagen triple-helix encoding region of either the COL1A1 or COL1A2 gene)
•3. Age between 4 to 8 years
•4. Parent/legal guardian over 18 years of age

Exclusion Criteria

•1. Existence of other known disorder that might interfere with the treatment (such as severe malformations, congenital heart defect, hypoxic encephalopathy (l-lll), neurological problems, immune deficiencies, muscle diseases, syndromes) diagnosed by clinical examination
•2. Any contraindication for invasive procedures such as a moderate/severe bleeding tendency or contagious infections
•3. Abnormal karyotype or other confirmed genetic syndromes
•4. Oncologic disease
•5. Inability to comply with the trial protocol and evaluation and follow-up schedule
•6. Inability to understand the information and to provide informed consent

Locations (1)

Christian Medical College

Vellore, Tamil Nadu, India

Key Dates

Start Date

May 20, 2019

Primary Completion Date

November 1, 2021

Completion Date

December 1, 2021

Last Updated

November 10, 2020

Enrollment

ESTIMATED participants

Conditions

Osteogenesis Imperfecta

Interventions

BOOST cells

BIOLOGICAL

Contacts

Vrisha Madhuri, MS Orth

CONTACT

91-416-2282172 madhuriwalter@cmcvellore.ac.in

Suhasini Ganesh, M.Pharm

CONTACT

91-416-2285117 brittlebonekids@cmcvellore.ac.in

Effects of Bisphosphonates on OI-Related Hearing Loss

NCT04152551

Osteogenesis Imperfecta

View study

ACTIVE_NOT_RECRUITING

Cardiopulmonary Outcomes in Osteogenesis Imperfecta: BBD7708

NCT05317637

Osteogenesis Imperfecta

View study

ACTIVE_NOT_RECRUITINGPHASE1/PHASE2

Boost Brittle Bones Before Birth

NCT03706482

Osteogenesis Imperfecta

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 10, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Effects of Bisphosphonates on OI-Related Hearing Loss

Cardiopulmonary Outcomes in Osteogenesis Imperfecta: BBD7708

Boost Brittle Bones Before Birth

Evaluation and Intervention for the Effects of Osteogenesis Imperfecta

Mesenchymal Cell Therapy in Osteogenesis Imperfecta (OI)

Treatment of Osteogenesis Imperfecta With Parathyroid Hormone and Zoledronic Acid