Alveolar Cleft Clinical Trial
Official title:
"Use of Autologous Umbilical Cord Stem Cell Transplantation in the Reconstruction of Alveolar Cleft "
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.
Status | Not yet recruiting |
Enrollment | 20 |
Est. completion date | June 30, 2022 |
Est. primary completion date | November 30, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 3 Months to 6 Months |
Eligibility | 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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Makerere University |
7. Bajestan MN, Rajan A, Edwards SP, et al. Stem cell therapy for reconstruction of alveolar cleft and trauma defects in adults: A randomized controlled, clinical trial. Clin Implant Dent Relat Res. 2017;19(5):793?801. doi:10.1111/cid.12506 8. Hee Jung Kim, Jeong-Soo Park Usage of Human Mesenchymal Stem Cells in Cell-based Therapy: Advantages and Disadvantages 9. Dev Reprod. 2017 Mar; 21(1): 1-10. Published online 2017 Mar 31. doi: 10.12717/DR.2017.21.1.001 10. Kang NH. Current Methods for the Treatment of Alveolar Cleft. Arch Plast Surg. 2017;44(3):188?193. doi:10.5999/aps.2017.44.3.188
Bhattacharya S, Khanna V, Kohli R. Cleft lip: The historical perspective. Indian J Plast Surg. 2009 Oct;42 Suppl:S4-8. doi: 10.4103/0970-0358.57180. — View Citation
Coots BK. Alveolar bone grafting: past, present, and new horizons. Semin Plast Surg. 2012 Nov;26(4):178-83. doi: 10.1055/s-0033-1333887. — View Citation
Mazzetti MPV, Alonso N, Brock RS, Ayoub A, Massumoto SM, Eça LP. Importance of Stem Cell Transplantation in Cleft Lip and Palate Surgical Treatment Protocol. J Craniofac Surg. 2018 Sep;29(6):1445-1451. doi: 10.1097/SCS.0000000000004766. — View Citation
Tanikawa DYS, Pinheiro CCG, Almeida MCA, Oliveira CRGCM, Coudry RA, Rocha DL, Bueno DF. Deciduous Dental Pulp Stem Cells for Maxillary Alveolar Reconstruction in Cleft Lip and Palate Patients. Stem Cells Int. 2020 Mar 12;2020:6234167. doi: 10.1155/2020/6234167. eCollection 2020. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Development of side effects. | 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. |
one month | |
Primary | Alveolar bone density | Alveolar bone density: this will be measured in mm by one radiologist. | 6 months | |
Primary | Alveolar bone volume | Chelsea scale will be used to score the alveolar bone volume. | 6 months |
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