Clinical trial: Safety Study of Gintuit™ in Subjects Requiring Socket Grafting (NCT01929954)

Eligibility criteria:
Inclusion Criteria:

          -  Subject is at least 18 years of age but no more than 75 years of age.

          -  Subject has a posterior (molar or premolar) socket created by atraumatic extraction
             with a post extraction socket of a minimum of 5 mm in both the mesial-distal (M-D) and
             buccal-lingual (B-L) dimensions that requires bone grafting.

          -  Subject has sufficient buccal bone plate at the site of the planned tooth extraction
             (ie, the residual socket should be of a form that would retain bone graft material),
             as judged by the Principal Investigator.

          -  Females of childbearing potential must have a documented negative urine pregnancy
             test. All subjects must agree to use acceptable methods of contraception for the
             duration of the study.

          -  Subjects must have read, understood, and signed an institutional review board
             (IRB)-approved Informed Consent Form (ICF).

          -  Subjects must be able and willing to comply with protocol requirements.

        Exclusion Criteria:

          -  Subject with any systemic conditions that could compromise wound healing and preclude
             periodontal surgery (ie, bleeding disorder, cancer, except localized basal cell or
             squamous cell cancer of the skin with no metastasis; human immunodeficiency virus; or
             bone metabolic diseases [ie, osteoporosis or Paget's disease]).

          -  Subject who is currently receiving, anticipates receiving or has received within 30
             days prior to Day 0: inhaled or systemic corticosteroids (ie, oral, IV),
             immunosuppressive agents or radiation therapy, and/or chemotherapy, which could
             compromise wound healing and preclude periodontal surgery.

          -  Subject who has had oral/periodontal surgery within 30 days prior to Day 0 or
             anticipates having oral/periodontal surgery within 30 days after Day 0.

          -  Subject with acute mucosal infection, including suppuration or induration in the area
             of intended surgery.

          -  Subject, who in the opinion of the Principal Investigator, will require a sinus lift
             procedure to place dental implants in the surgical area.

          -  Subject without at least 1 tooth adjacent to the area to be treated.

          -  Subject has a history of alcohol or substance abuse within the previous 12 months of
             Screening that could interfere with study compliance or protocol requirements.

          -  Subject who has used any tobacco product within 6 months of Screening.

          -  Subject with known hypersensitivity to porcine or bovine collagen, gentamicin or
             surfactants.

          -  Subject who has received an investigational drug, device, or biological/bioactive
             treatment within 30 days prior to Day 0 (medical or dental).

          -  Subject who was previously treated with Gintuit, or any other cell therapy at the
             target treatment site or immediately adjacent teeth.

          -  Female subject that is lactating.

          -  Subject, who in the opinion of the Principal Investigator, for any reason other than
             those listed above, will not be able to complete the study per protocol.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 75 Years

Patient description (medical language): A 23-year-old female has prolonged oral bleeding immediately after a tooth extraction.  Despite several interventions, the bleeding persists for hours and stops only after desmopressin (DDAVP) administration.  The patient has heavy menstrual cycles each month.  She has no other medical problems and takes no medications.  Her mother and grandmother have also had excessive bleeding during menstrual period.  Review of systems is positive for mild bruising on his legs. Laboratory findings reveal a normal platelet count and an abnormal ristocetin cofactor assay, as well as CB <= 0.30 IU/mL and FVIII:C <= 0.40 IU/mL.

Patient description (patient's own words): I'm a 23 woman and I went to the ER because of non-stop bleeding after my tooth extraction. I tried to make the bleeding stop but it just kept going for hours and it finally stopped when I took some medication called DDAVP. I usually have heavy periods, just like my mom and grandma had. I don't have any other medical condition and I don't take any other medication. The doctor noticed the bruises on my legs. I had to do some lab tests. I had a normal platelet count but an abnormal ristocetin cofactor assay. I had low CB and FVIII:C levels.

Does the patient match the trial criteria? Contradiction