Sensitization test of the digital coralline hydroxyapatite artificial bone scaffold at the maximal dosage / 中国组织工程研究

ABSTRACT

BACKGROUND:We have successfuly prepared digital coraline hydroxyapatite artificial bone scaffold in previous experiments, and it has been confirmed that it has the necessary physical and chemical properties of bone tissue engineering scaffolds. OBJECTIVE: To evaluate the sensitization of digital coraline hydroxyapatite artificial bone scaffold. METHODS:A total of 32 guinea pigs were randomly divided into saline group (negative control group, n=8), 5% formaldehyde group (positive control group,n=8), experimental A group (the mass ratio of 31,n=8), and experimental B group (the mass ratio of 41,n=8). Sensitization test at the maximal dosage was performed according toBiological Evaluation of Medical Devices-Part 10 Tests for Irritation and Delayed-Type Hypersensitivity, including intracutaneous induction, local induction, and provocation. Patch was removed after 24 and 48 hours, and the skin response was classified according to Magnusson and Kligman criteria. Patch was removed after 48 hours, and the skin was performed with biopsy, stained with hematoxylin-eosin, and observed under optical microscope. RESULTS AND CONCLUSION: Sensitization response was not tested in the negative control group, experimental A group and experimental B group at 24 and 48 hours after patch removal; however, moderate erythema was observed in the positive control group. Optical microscope demonstrated that spongiosis, edema, diffuse or perivascular mononuclear infiltration was not observed, and only a smal number of basicytes were seen in the experimental A and B groups. These findings indicate that the digital coral hydroxyapatite artificial bone scaffolds, with the mass ratio of 31 and 41, are biologicaly safe for sensitization.