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NCT04886947
Alveolar Cleft Reconstruction Powered by
NA trial testing stem cell transplantation in Alveolar Cleft in 20 participants. Status unknown.
30 November 2021
Quick facts
| Lead sponsor | Makerere University |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 1 June 2021 |
| Primary completion | 30 November 2021 |
| Estimated completion | 30 June 2022 |
Drugs / interventions tested
- stem cell transplantation — full drug profile →
Conditions studied
- Alveolar Cleft — all drugs for Alveolar Cleft →
Sponsor
Makerere University
Who can join
Adults 3 Months to 6 Months, any sex, with Alveolar Cleft. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04886947
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Related trials
Other trials of stem cell transplantation
Trials testing the same drug.
- NCT04062136 — Umbilical Cord Mesenchymal Stem Cells Transplantation in the Treatment of Bronchopulmonary Dysplasia · Phase 1 · completed
- NCT03263767 — Post Transplant Cyclophosphamide (PTCY) as Sole Graft Versus Host Disease (GVHD) Prophylaxis for Matched Allotransplant: · Phase 2 · terminated
- NCT02323477 — Human Umbilical Cord Stroma MSC in Myocardial Infarction · Phase 1, PHASE2 · terminated
- NCT00303719 — Allogeneic Bone Marrow Transplantation Using Less Intensive Therapy · Phase 2 · terminated
Other recruiting trials for Alveolar Cleft
Currently open trials in the same condition.
- NCT06585566 — Alveolar Cleft Reconstruction With Cortical-Shells · NA · recruiting
Other Makerere University trials
Trials by the same sponsor.
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- NCT06139198 — Self-management Intervention for Reducing Epilepsy Burden Among Ugandans With Epilepsy. · NA · recruiting
- NCT06791928 — Peer Delivered HIV/Syphilis Self-Testing With Assisted Partner Notification Services · Phase 2 · enrolling by invitation
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04886947 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Makerere University
- Last refreshed: 14 May 2021
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