"Use of Autologous Umbilical Cord Stem Cell Transplantation in the Reconstruction of Alveolar Cleft "
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 主要终点
- Alveolar bone density
研究概览
简要总结
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.
详细描述
A lot has progressed in the care of Cleft lip and palate with development of multidisciplinary team approach. Despite these achievements there are still a lot of challenges in the treatment of alveolar cleft. Alveolar cleft being the less conspicuous component of the cleft abnormality attracted less interest in its correction; its treatment history dates in the not-so-distant past were as cleft lip history repair dates as far as 390 Before Christ and palate repair in 1764. The first attempt to treat alveolar cleft with bone graft was in 1901 then again in 1908 but it was not until 1914 that Dracher was the first to perform a successful bone graft of the alveolar defect using tibial bone that gave birth to the primary alveolar bone graft. This approach was later found to be destructive to the developing face and was abandoned. Then in 1972 Secondary bone grafting of maxilla and residual alveolar clefts at the stage of transitional dentition this become popular in some centers.
In 1967 Swedish Plastic Surgeon Tord Skoog introduced yet a new concept called boneless alveolar graft or primary periosteoplasty (PPP) which he performed during the time of lip repair at 3 months in this repair periosteal flaps were raised clearing soft tissue between the alveolar defect and the flaps were closed to form a tunnel at the time of lip repair. This was because it was believed that with time bone would form in the tunnel and so bone graft will not be needed. Follow up in many studies indicated bone developed in the tunnel in about 60 to 72% of the cases. His follow up study up to the age of 18years indicated that despite a delay in facial growth at early age by 18 years all are at the same level.
This study 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 in African population. All the documented studies are conducted only in non-African populations which have slightly different phenotype and use to pre-surgical orthodontic treatment.
Stem-cells are un-differentiated progenitor cells capable of self-renewal and differentiation into any specialized cells. Umbilical cord stem cells in gingivoperiosteoplasty has shown good bone regeneration in alveolar cleft and minimizing the donor mobility. But there is a need for us to establish its possibility and effectiveness in out setting. This will be the first stem cell trial in cleft treatment protocol in our region . With the establishment of a stem cell center at Makerere and recently funded to improve its capacity, we believe we can contribute to the improvement of cleft care in Uganda.
Problem statement The current accepted gold standard protocol for alveolar defect is controversial on timing, outcome, and associated morbidity. Therefore, the second common protocol of Gingivoperiosteoplasty (GPP) carried out during primary lip repair at 3 to 6 months would provide a better alternative by providing early repair with a smaller number of surgeries and also obviate the need for secondary bone graft with further use of stem cell transplant. The use of umbilical stem cell transplantation in gingivoperiosteoplasty procedure has only been done in 10 cases and the results indicate good bone regeneration in the alveolar bone defect. Despite the demonstration of success in the previous stem cell therapy there is need to do a clinical trial in African population to prove the role and use of stem cells in alveolar bone regeneration in our setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
The radiologist interpreting bone formation of the alveolar will be blinded on which group the participants belongs. whether no or intervention done
入排标准
- 年龄范围
- 3 Months 至 6 Months(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neonates with unilateral cleft lip and palate and having clinical evidence of alveolar defect.
排除标准
- •Patients with very wide cleft lip and palate Patients whose parents refuse consent Patients with Syndromic cleft
结局指标
主要结局
Alveolar bone density
时间窗: 6 months
Alveolar bone density: this will be measured in mm by one radiologist.
Alveolar bone volume
时间窗: 6 months
Chelsea scale will be used to score the alveolar bone volume.
次要结局
未报告次要终点
