Concomitant Use of Buccal Fat Pad Derived Cells and Autogenous Bone in Alveolar Cleft Osteoplasty

NCT02859025 | Completed Phase 1

• 1 other identifier: sbmu9221
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Cleft of Alveolar Ridge

Keywords

Alveolar cleft; Osteoplasty; Tissue engineering; Stem cells; Regenerative medicine; Bone; Lateral ramus

Outcome Measures

Primary Outcomes (1)

• change in bone volume

  1-mm coronal sections of the treated region were taken before and after surgery, and new bone formation was assessed by CBCT.

  before the surgery and 6 months after the surgery

Study Arms (3)

A:Iiac

ACTIVE COMPARATOR

Treated with anterior iliac crest spongy bone to fill defects, followed by coverage with collagen membrane.

Biological: anterior iliac crest graft

B:MSCs+LRCP

EXPERIMENTAL

Treated with lateral ramus cortical bone plate (LRCP) to create a protected healing space by fixing it to adjacent walls of the cleft defect. BFPScs were loaded on NBBM and delivered to the defect

Biological: lateral ramus cortical bone+BFPSC+NBBM

C:MSCs+liac

EXPERIMENTAL

Treated with anterior iliac crest spongy bone as in Group 1, but BFP-derived mesenchymal stem cells (MSCs ) cultured over NBBM were put over the spongy bone and covered with a collagen membrane.

Biological: anterior iliac crest graft+BFPSC+NBBM

Interventions

anterior iliac crest graft BIOLOGICAL

Anterior iliac crest spongy bone filled the defects followed by coverage with collagen membrane.

A:Iiac

lateral ramus cortical bone+BFPSC+NBBM BIOLOGICAL

ramus cortical bone cage created a protected healing space and BFPSCs cultured over NBBM were put over the graft.

B:MSCs+LRCP

anterior iliac crest graft+BFPSC+NBBM BIOLOGICAL

Anterior iliac crest spongy bone filled the defects and BFPSCs cultured over NBBM were put over the spongy bone.

C:MSCs+liac

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shahid Beheshti University of Medical Sciences: lead

Study Sites (1)

School of Dentristry at Shahid Beheshti University of Medical Sciences

Tehran, Tehran Province, 19839, Iran

Location

Related Publications (1)

• 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.

  PMID: 29379800 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: July 30, 2016
• First Posted: August 8, 2016
• Study Start: January 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: February 1, 2016
• Last Updated: August 8, 2016

Record last verified: 2016-08

Locations

IR (1)