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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Recruitment Status : Withdrawn (Did not obtain IRB approval)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
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Study Description
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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
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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
Arms and Interventions
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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
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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
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Information from the National Library of Medicine

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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
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Information from the National Library of Medicine

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


Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Mike Sabeti, DDS University of California, San Francisco
More Information
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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

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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 University of California, San Francisco:
Pulpal regeneration
Stem cells
Residual Pulpal Tissue
Irreversible Pulpitis
Additional relevant MeSH terms:
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Pulpitis
Dental Pulp Diseases
Tooth Diseases
Stomatognathic Diseases