Residual Dental Pulp Tissue and Cord Blood Stem Cells

• ClinicalTrials.gov Identifier: NCT04040127
• Recruitment Status: Not yet recruiting
• First Posted: July 31, 2019
• Last Update Posted: August 2, 2019
• Sponsor: University of California, San Francisco
• Information provided by (Responsible Party): Mike Sabeti, University of California, San Francisco

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Irreversible Pulpitis	Biological: Cord blood stem cells; Other: Saline solution	Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 40 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

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. Regeneration of pulp [ Time Frame: 6-9 months ]
   Absence of clinical symptoms and signs as well as response to thermal testing.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Contacts

Contact: Mike Sabeti, DDS; 415-476-0822; mike.sabeti@ucsf.edu

Contact: Jason Kwok, DDS; 650-731-5029; jason.kwok@ucsf.edu

Sponsors and Collaborators

University of California, San Francisco

Investigators

• Principal Investigator: Mike Sabeti, DDS; University of California, San Francisco

More Information

• Responsible Party: Mike Sabeti, Principal Investigator, University of California, San Francisco
• ClinicalTrials.gov Identifier: NCT04040127 History of Changes
• Other Study ID Numbers: 19-27622
• First Posted: July 31, 2019
• Last Update Posted: August 2, 2019
• Last Verified: July 2019

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

Keywords provided by Mike Sabeti, University of California, San Francisco:

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

Additional relevant MeSH terms:

Pulpitis; Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases; Pharmaceutical Solutions