Tissue Engineered Constructs for Alveolar Cleft Repair

Cairo University (CU)

Status: Completed

Conditions: Cleft Lip and Palate

Treatments: Procedure: autogenous bone graft group; Other: tissue engineered group

Study type: Interventional

Funder types: Other

Identifiers

NCT03563495

MSCs in alveolar cleft repair

Details and patient eligibility

About

Description of the research question

In children undergoing unilateral alveolar cleft reconstruction, would stem cells carried on collagen scaffold provide bone of a good quality and quantity if compared to autogenous bone grafting?

Objective of the study:

• Research hypothesis

The tissue engineered constructs will provide sufficient bone of a good quality and quantity if compared to autogenous bone graft in children undergoing unilateral alveolar cleft reconstruction.

• The objectives

The primary objective:

Assessment of bone volume (quantity) which will be provided by tissue engineered constructs compared to that provided by autogenous bone for maxillary alveolar cleft reconstruction.

The secondary objective:

Assessment of bone density (quality) which will be provided by tissue engineered constructs compared to that provided by autogenous bone for maxillary alveolar cleft reconstruction.

Enrollment: 10 patients

Sex: All

Ages: 8 to 14 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Children with maxillary unilateral alveolar clefts requiring reconstruction
• Children free from any systemic disease that may affect normal healing of bone
• Children in an age range (8-14) year.

Exclusion criteria

• Bilateral alveolar clefts.
• Cleft lip or palate not including the alveolus.
• Immunocompromized patients.
• Children who undergone previous bone grafting procedure for the alveolar cleft

Trial design

10 participants in 2 patient groups

tissue engineered group

Active Comparator group

Description:

autogenous bone marrow derived and cultured stem cells loaded on collagen matrix was implanted in the alveolar cleft in the study group (1st arm)

Treatment:

Other: tissue engineered group

autogenous bone graft group

Active Comparator group

Description:

autogenous cortico-cancellous bone graft harvested from the anterior iliac crest was implanted in the alveolar cleft of the control group (2nd arm)

Treatment:

Procedure: autogenous bone graft group