Residual Dental Pulp Tissue and Cord Blood Stem Cells

• ClinicalTrials.gov Identifier: NCT04040127
• Recruitment Status: Withdrawn
• First Posted: July 31, 2019
• Last Update Posted: July 27, 2020
• Sponsor: University of California, San Francisco
• Information provided by (Responsible Party): University of California, San Francisco

Tracking Information

• First Submitted Date: July 30, 2019
• First Posted Date: July 31, 2019
• Last Update Posted Date: July 27, 2020
• Estimated Study Start Date: September 1, 2019
• Estimated Primary Completion Date: January 15, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 30, 2019)

Regeneration of pulp [ Time Frame: 6-9 months ]

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

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.
• Study Type: Interventional
• Study Phase: Phase 2

Study Design

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

• Condition: Irreversible Pulpitis

Intervention

• 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℃.
• Other: Saline solution
  saline solution used to rinse the canal.

Study Arms

• Experimental: Cord blood stem cells
  cord blood stem cells from Invitrx
  Intervention: Biological: Cord blood stem cells
• Placebo Comparator: 0.9% sodium chloride (saline)
  canal will be rinsed by saline solution.
  Intervention: Other: Saline solution

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Withdrawn
• Actual Enrollment (submitted: July 23, 2020): 0
• Original Estimated Enrollment (submitted: July 30, 2019): 40
• Estimated Study Completion Date: February 28, 2020
• Estimated Primary Completion Date: January 15, 2020 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT04040127
• Other Study ID Numbers: 19-27622
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: University of California, San Francisco
• Study Sponsor: University of California, San Francisco
• Collaborators: Not Provided

Investigators

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

• PRS Account: University of California, San Francisco
• Verification Date: July 2020