Residual Dental Pulp Tissue and Cord Blood Stem Cells

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Residual Dental Pulp Tissue and Cord Blood Stem Cells on Regeneration of Dental

Conditions
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Irreversible Pulpitis

Intervention / Treatment
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* Biological: Cord blood stem cells
* Other: Saline solution


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cord blood stem cells<br>cord blood stem cells from Invitrx | Biological: Cord blood stem cells<br>* 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℃.<br>|
| Placebo Comparator: 0.9% sodium chloride (saline)<br>canal will be rinsed by saline solution. | Other: Saline solution<br>* saline solution used to rinse the canal.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Regeneration of pulp | Absence of clinical symptoms and signs as well as response to thermal testing. | 6-9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pulpal regeneration, Stem cells, Residual Pulpal Tissue, Irreversible Pulpitis