Residual Dental Pulp Tissue and Cord Blood Stem Cells
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ClinicalTrials.gov Identifier: NCT04040127 |
Recruitment Status :
Withdrawn
(Did not obtain IRB approval)
First Posted : July 31, 2019
Last Update Posted : July 27, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Irreversible Pulpitis | Biological: Cord blood stem cells Other: Saline solution | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | Randomized |
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. |
Primary Purpose: | Treatment |
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 |
Arm | Intervention/treatment |
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Experimental: Cord blood stem cells
cord blood stem cells from Invitrx
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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.
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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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
A. Patients must be systemically healthy, Class I dental category. B. Involved teeth must have no periodontal disease detectible by periodontal examination.
C. Patients must present without radiographic signs of endodontic disease (i.e. no periapical radiolucencies).
Exclusion Criteria:
A. Presence of any disease or medication that alters the immune system or interferes with healing ability B. Smokers (more than 10 cigarettes per day) C. External or internal tooth resorption D. Tooth perforation from the pulp cavity through the tip of the root exposing the tissue to material in the oral cavity.
E. Pregnant or nursing mothers because hormonal factors may influence the condition.
F. Allergies or adverse reactions to local anesthetic medications G. Patients under the age of 18. H. Patients with an ASA Classification II or higher

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
Principal Investigator: | Mike Sabeti, DDS | University of California, San Francisco |
Responsible Party: | University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT04040127 |
Other Study ID Numbers: |
19-27622 |
First Posted: | July 31, 2019 Key Record Dates |
Last Update Posted: | July 27, 2020 |
Last Verified: | July 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | Yes |
Pulpal regeneration Stem cells Residual Pulpal Tissue Irreversible Pulpitis |
Pulpitis Dental Pulp Diseases Tooth Diseases Stomatognathic Diseases |