Residual Dental Pulp Tissue and Cord Blood Stem Cells

NCT04040127 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: 19-27622
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Pulpal regeneration; Stem cells; Residual Pulpal Tissue; Irreversible Pulpitis

Outcome Measures

Primary Outcomes (1)

• Regeneration of pulp

  Absence of clinical symptoms and signs as well as response to thermal testing.

  6-9 months

Study Arms (2)

Cord blood stem cells

EXPERIMENTAL

cord blood stem cells from Invitrx

Biological: Cord blood stem cells

0.9% sodium chloride (saline)

PLACEBO COMPARATOR

canal will be rinsed by saline solution.

Other: Saline solution

Interventions

Cord blood stem cells BIOLOGICAL

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℃.

Cord blood stem cells

Saline solution OTHER

saline solution used to rinse the canal.

0.9% sodium chloride (saline)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead

MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Mike Sabeti, DDS

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Syringe with the intervention and control will be covered with masking tape in order for both the provider and the participant to be blind.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 30, 2019
• First Posted: July 31, 2019
• Study Start: September 1, 2019
• Primary Completion: January 15, 2020
• Study Completion: February 28, 2020
• Last Updated: July 27, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share