Clinical trial NCT02859025: Concomitant Use of Buccal Fat Pad Derived Cells and Autogenous Bone in Alveolar Cleft Osteoplasty
Official title: Lateral Ramus Cortical Bone Plate in Alveolar Cleft Osteoplasty: Concomitant Use of Buccal Fat Pad Derived Cells and Autogenous Bone in a Preliminary Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cleft of Alveolar Ridge
Keywords: Alveolar cleft
Osteoplasty
Tissue engineering
Stem cells
Regenerative medicine
Bone
Lateral ramus
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2016-08-08
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Our aim was to combine regenerative techniques with bone grafting in human models to increase predictability and survival of reconstructed tissue. The MSCs in this study were derived from an intra oral fat source (BFP) and were cultured over natural bovine bone mineral granules and delivered within the lateral ramus cortical bone plate (LRCP)to treat human alveolar cleft defects.

Detailed description: Patients enrolled in the present study were suffering from alveolar cleft and had previously received orthodontic treatment and only required secondary alveolar grafting. The buccal fat pad derived stem cells (BFPSCs) were harvested from buccal fat pad tissues of the patients. Patients were divided into 3 groups. Group A , the control group, was treated with anterior iliac crest (AIC) spongy bone to fill defects, followed by coverage with collagen membrane. Group B was treated with lateral ramus cortical bone cage (LRCP), used to create a protected healing space by fixing it to adjacent walls of the cleft defect. Group C was treated with (AIC) as in Group 1, but BFP-derived MSCs cultured over NBBM were put over the spongy bone and covered with a collagen membrane.Passage 3 BFPSCs were loaded on the implants ( Cerabone (Botiss, Berlin, Germany) a natural bovine bone mineral (NBBM); a granular biomaterial with a 200- to 850-µm particle size) 3 days prior to transplantation.Cone beam computed tomography (CBCT) was obtained after 6 months.

Eligibility criteria: Inclusion Criteria:

* Unilateral congenital cleft lip and palate
* Previous presurgical orthodontic treatment

Exclusion Criteria:

* History of malignancy
* History of radiation
* History of chemotherapy
* Pregnancy
* Systemic diseases contradicting dental and surgical treatments
* Conditions or drugs affecting bone remodeling or bone metabolism and connective tissue
* Allergy to collagen

Primary outcomes:
measure: change in bone volume
timeFrame: before the surgery and 6 months after the surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: School of Dentristry at Shahid Beheshti University of Medical Sciences
Study officials:
References:
citation: Khojasteh A, Kheiri L, Behnia H, Tehranchi A, Nazeman P, Nadjmi N, Soleimani M. Lateral Ramus Cortical Bone Plate in Alveolar Cleft Osteoplasty with Concomitant Use of Buccal Fat Pad Derived Cells and Autogenous Bone: Phase I Clinical Trial. Biomed Res Int. 2017;2017:6560234. doi: 10.1155/2017/6560234. Epub 2017 Dec 12.