Evaluation of the effect of adipose tissue - mononuclear cells (AT-NMCs) on maxillofacial bone regeneration: a randomized, controlled clinical trial and phase 1

The main objective of this study is evaluating the safety of using mononuclear cells isolated from adipose tissue to regeneration bone tissue in patients with an oral maxillofacial bone defect after 6 months from surgery.

A clinical trial with a control group, parallel, randomized

The present study provides a cell therapy approach for improvement of bone regeneration in oral-maxillofacial defects. the study will be performed in the Ayatollah Taleghani Hospital, Shahid Beheshti University of medical sciences. Twenty patients with an oral-maxillofacial defect will be selected randomly based on inclusion and exclusion criteria. After general anesthesia, in the test group, adipose tissue will be harvested and mononuclear cells isolated by mechanical method during the surgery. Then cells will be transplanted to defect site along with routine scaffold. Patients in the control group will have surgery by implantation only scaffold in the defect site, as a routine technique. moreover, blinding was no performed.

Inclusion criteria: -The patient has a bone defect in the maxillofacial region non-inclusion criteria: -The defect should not be socket, dehiscence, fenestration, and also sinus not involved. -systemic and metabolic diseases -active infection -compromised immune system -pregnant and or lactating women -osteoporosis and osteopetrosis -previous alveolar surgery -smoking

intervention group: the transplantation mononuclear cell isolation of fat tissue autologous and bone scaffolds to improve defect bone in the oral maxillofacial region control group: the transplantation bone graft to defect bone in the oral maxillofacial region

the primary outcome of this trial is safety

In this study, randomization is performed using the block method using SAS software. twenty patient will be involved in the study, which will be classified into two groups. to avoid identifying the last patient by medical staff, 5 blocks with 6 wells will be designed that only 4 wells per each block will be considered. To conceal randomization, each block will be placed in an envelope and all researchers will unaware of the contents of the envelopes. Therefore, a non-study individual was selected to perform all these steps to inform the physician of the result.