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Residual Dental Pulp Tissue and Cord Blood Stem Cells

University of California San Francisco (UCSF) logo

University of California San Francisco (UCSF)

Status and phase

Withdrawn
Phase 2

Conditions

Irreversible Pulpitis

Treatments

Other: Saline solution
Biological: Cord blood stem cells

Study type

Interventional

Funder types

Other

Identifiers

NCT04040127
19-27622

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

Accepts 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

0 participants in 2 patient groups, including a placebo group

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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