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Alveolar Cleft Reconstruction Powered by

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ClinicalTrials.gov Identifier: NCT04886947
Recruitment Status : Not yet recruiting
First Posted : May 14, 2021
Last Update Posted : May 14, 2021
Sponsor:
Information provided by (Responsible Party):
Makerere University

Brief 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.


Condition or disease Intervention/treatment Phase
Alveolar Cleft Procedure: stem cell transplantation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: case control study with control being those receiving convectional treatment and cases those will have added intervention of autologues stem cell
Masking: None (Open Label)
Masking Description: The radiologist interpreting bone formation of the alveolar will be blinded on which group the participants belongs. whether no or intervention done
Primary Purpose: Treatment
Official Title: "Use of Autologous Umbilical Cord Stem Cell Transplantation in the Reconstruction of Alveolar Cleft "
Estimated Study Start Date : June 1, 2021
Estimated Primary Completion Date : November 30, 2021
Estimated Study Completion Date : June 30, 2022

Arm Intervention/treatment
Experimental: stem cell intervention

Arm A patients who will have surgery with stem cell added.

Arm B only surgery with no stem cell added.

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.




Primary Outcome Measures :
  1. Alveolar bone density [ Time Frame: 6 months ]
    Alveolar bone density: this will be measured in mm by one radiologist.

  2. Alveolar bone volume [ Time Frame: 6 months ]
    Chelsea scale will be used to score the alveolar bone volume.


Other Outcome Measures:
  1. Development of side effects. [ Time Frame: one month ]

    Development of side effects. These will be graded as either Mild: Awareness of a sign or symptom which does not interfere with the participants usual daily activities or is transient and resolves with the use of simple interventions.

    Moderate: Interferes with the participants usual daily activity and required symptomatic treatment including analgesia Severe: Symptoms causing severe discomfort with significant impact of the participant's usual daily activity.

    Serious: Any unexpected medical incident which requires hospitalization or results in long term disability or death.




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Ages Eligible for Study:   3 Months to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Neonates with unilateral cleft lip and palate and having clinical evidence of alveolar defect.

Exclusion Criteria:

- Patients with very wide cleft lip and palate Patients whose parents refuse consent Patients with Syndromic cleft


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04886947


Contacts
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Contact: rose alenyo, m.med 0772608026 alenyom@yahoo.co.uk
Contact: ronald mbine, m.med 0774338585 mbineron@gmail.com

Sponsors and Collaborators
Makerere University
Investigators
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Study Director: naknwagi cephas, bachelor Makerere University
Publications:
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Responsible Party: Makerere University
ClinicalTrials.gov Identifier: NCT04886947    
Other Study ID Numbers: MAKRIF/DVCFA/025/20
First Posted: May 14, 2021    Key Record Dates
Last Update Posted: May 14, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: there will be no participants data sharing

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Makerere University:
alveolar cleft stem cell gingivoperiosteoplasty