Trials / Withdrawn
WithdrawnNCT04040127
Residual Dental Pulp Tissue and Cord Blood Stem Cells
Effect of Residual Dental Pulp Tissue and Cord Blood Stem Cells on Regeneration of Dental
- Status
- Withdrawn
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- University of California, San Francisco · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
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.
Detailed description
Patients will be recruited from the various dental clinics at UCSF (student clinic, Advanced Education in General Dentistry clinic, post-graduate endodontics clinic, etc) that meet the inclusion and exclusion criteria. Patients in the control group will have root canal therapy initiated; instrumentation and cleaning up to 4mm from the radiographic apex. Bleeding will be induced and blood clot formed 3mm from the CEJ. MTA followed by glass ionomer and composite will be placed over the clot. Patients in the experimental group will have root canal therapy initiatied; instrumentation and cleaning up to 4mm from the radiographic apex. Bleeding will be induced and blood clot formed 3mm from the CEJ. 1 cc (30 million cord blood stem cells) will then be injected into the clot formation. MTA followed by glass ionomer and composite will be placed over the clot.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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℃. |
| OTHER | Saline solution | saline solution used to rinse the canal. |
Timeline
- Start date
- 2019-09-01
- Primary completion
- 2020-01-15
- Completion
- 2020-02-28
- First posted
- 2019-07-31
- Last updated
- 2020-07-27
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04040127. Inclusion in this directory is not an endorsement.