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Alveolar Cleft Reconstruction Powered by

NCT04886947 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2021-05-14

No results posted yet for this study

Summary

More than four million children are born with birth defects worldwide every year and a million presenting with cleft lip and palate. Cleft lip and palate is a congenital defect of the lip alveolar and palate it's now recognized as a significant cause of infant mortality and childhood morbidity and included among global burden of disease initiative. In Uganda the estimated number of babies born with cleft lip and palate is 1100 per year Children with 75% of them having alveolar cleft which is a defect in the upper jaw (Maxilla arch).

The secondary bone graft and gingivoperiosteoplasty have become the two popular approaches to bone generation in alveolar defect. These two methods have varying success rates; primary gingivoperiosteoplasty 50 to 60% and secondary bone graft is 87% but Gingivoperiosteoplasty is the preferred option to many African surgeons to obviate the need for bone grafting which is technically demanding, prolonging therapy with many procedures therefore poor compliance, also increasing treatment failure rate and has significant associated donor morbidity. This project is set out to address the challenge of bone regeneration in alveolar cleft and improve on the surgical outcome by the use of stem cell therapy.

The objective of this study is to compare the outcome of umbilical cord blood stem cell transplant plus gingivoperiosteoplasty to conventional gingivoperiosteoplasty on timing and density of bone regeneration.

1.3. Hypothesis In this study we hypothesize that primary repair with gingivoperiosteoplasty the success rate can be improved or enhanced with the use of stem cell therapy in our setting.

Alternative hypothesis: Autologous umbilical stem cells transplantation following gingivoperiosteoplasty results in better bone regeneration when compared to gingivoperiosteoplasty.

Null hypothesis: Autologous umbilical stem cells transplantation following gingivoperiosteoplasty has no benefit on promoting bone regeneration when compared to gingivoperiosteoplasty alone.

The study will be a case control pilot study conducted in Kiruddu National Referral hospital Kampala Uganda. 20 participants who will be neonates of either sex with unilateral cleft lip and palate will be recruited in the study. They will be split into two groups: group A will have the umbilicus cord and placenta blood collected at birth and group B will not have umbilical cord or placenta blood collected and will be designated as the Control group.

Conditions

  • Alveolar Cleft

Interventions

PROCEDURE

stem cell transplantation

After surgical repair of alveolar cleft using gingivoperiosteoplasty, processed and stored autologous stem cells will be added at the repair site. After which the patient will be followed up for bone regeneration and this will be compared to control where no stem cell is added.

Sponsors & Collaborators

  • Makerere University

    lead OTHER

Principal Investigators

  • naknwagi cephas, bachelor · Makerere University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Months
Max Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-01
Primary Completion
2021-11-30
Completion
2022-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04886947 on ClinicalTrials.gov