Residual Dental Pulp Tissue and Cord Blood Stem Cells
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|ClinicalTrials.gov Identifier: NCT04040127|
Recruitment Status : Not yet recruiting
First Posted : July 31, 2019
Last Update Posted : August 2, 2019
|Condition or disease||Intervention/treatment||Phase|
|Irreversible Pulpitis||Biological: Cord blood stem cells Other: Saline solution||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||The experiments outlined in this proposal are designed to test the hypothesis that the in vivo injection of cord blood stem cells (InvitRx®) into the root canal system will facilitate teeth initially diagnosed with irreversible pulpitis, to form normal healthy pulpal tissue.|
|Masking:||Double (Participant, Care Provider)|
|Masking Description:||Syringe with the intervention and control will be covered with masking tape in order for both the provider and the participant to be blind.|
|Official Title:||Effect of Residual Dental Pulp Tissue and Cord Blood Stem Cells on Regeneration of Dental|
|Estimated Study Start Date :||September 1, 2019|
|Estimated Primary Completion Date :||January 15, 2020|
|Estimated Study Completion Date :||February 28, 2020|
Experimental: Cord blood stem cells
cord blood stem cells from Invitrx
Biological: Cord blood stem cells
Umbilical cords are collected from eligible donors at the time of delivery and transported to the processing facility on ice (2-8℃) in Dulbecco's Modified Eagle Media (DMEM). Cords are processed immediately under aseptic conditions and MSCs are collected for culture. Culture is maintained this way until the target number of cells has been reached, at which point passaged cells are suspended in Stem Cellbanker (Amsbio, Cambridge, MA) and frozen at -80℃.
Placebo Comparator: 0.9% sodium chloride (saline)
canal will be rinsed by saline solution.
Other: Saline solution
saline solution used to rinse the canal.
- Regeneration of pulp [ Time Frame: 6-9 months ]Absence of clinical symptoms and signs as well as response to thermal testing.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04040127
|Contact: Mike Sabeti, DDSfirstname.lastname@example.org|
|Contact: Jason Kwok, DDSemail@example.com|
|Principal Investigator:||Mike Sabeti, DDS||University of California, San Francisco|