search
Back to results

Residual Dental Pulp Tissue and Cord Blood Stem Cells

Primary Purpose

Irreversible Pulpitis

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Cord blood stem cells
Saline solution
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irreversible Pulpitis focused on measuring Pulpal regeneration, Stem cells, Residual Pulpal Tissue, Irreversible Pulpitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Cord blood stem cells

    0.9% sodium chloride (saline)

    Arm Description

    cord blood stem cells from Invitrx

    canal will be rinsed by saline solution.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    July 30, 2019
    Last Updated
    July 23, 2020
    Sponsor
    University of California, San Francisco
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04040127
    Brief Title
    Residual Dental Pulp Tissue and Cord Blood Stem Cells
    Official Title
    Effect of Residual Dental Pulp Tissue and Cord Blood Stem Cells on Regeneration of Dental
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2020
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Did not obtain IRB approval
    Study Start Date
    September 1, 2019 (Anticipated)
    Primary Completion Date
    January 15, 2020 (Anticipated)
    Study Completion Date
    February 28, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of California, San Francisco

    4. Oversight

    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
    Data Monitoring Committee
    Yes

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Irreversible Pulpitis
    Keywords
    Pulpal regeneration, Stem cells, Residual Pulpal Tissue, Irreversible Pulpitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    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
    ParticipantCare 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.
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Cord blood stem cells
    Arm Type
    Experimental
    Arm Description
    cord blood stem cells from Invitrx
    Arm Title
    0.9% sodium chloride (saline)
    Arm Type
    Placebo Comparator
    Arm Description
    canal will be rinsed by saline solution.
    Intervention Type
    Biological
    Intervention Name(s)
    Cord blood stem cells
    Intervention Description
    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℃.
    Intervention Type
    Other
    Intervention Name(s)
    Saline solution
    Intervention Description
    saline solution used to rinse the canal.
    Primary Outcome Measure Information:
    Title
    Regeneration of pulp
    Description
    Absence of clinical symptoms and signs as well as response to thermal testing.
    Time Frame
    6-9 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mike Sabeti, DDS
    Organizational Affiliation
    University of California, San Francisco
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Residual Dental Pulp Tissue and Cord Blood Stem Cells

    We'll reach out to this number within 24 hrs