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Residual Dental Pulp Tissue and Cord Blood Stem Cells

NCT04040127 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2020-07-27

No results posted yet for this study

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.

Conditions

  • Irreversible Pulpitis

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Mike Sabeti, DDS · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-09-01
Primary Completion
2020-01-15
Completion
2020-02-28
FDA Drug
Yes

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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 NCT04040127 on ClinicalTrials.gov