A Phase 1/2 interventional study of MSC-PLGA in Aneurysmal Bone Cyst, sponsored by Sophia Al-Adwan. Status unknown at 1 site in Jordan. Open to participants aged 4 Years to 28 Years. Per ClinicalTrials.gov, last updated 2019-07-24.
Sponsored by Sophia Al-Adwan · Phase 1/2, Interventional, and Treatment
Patients qualified for this study are those diagnosed with ABCs and failed to be treated with other forms of classical therapies. In which, these patients will be engrafted with biodegradable scaffolds seeded with Mesenchymal Stem Cells (MSCs) supplemented with Platelet lysate.
Aneurysmal bone cysts (ABC) are relatively rare, benign, tumor-like, expansile osteolytic lesions of unknown etiology which are predominantly found within the long bones and characterized by frequent idiopathic fractures. Despite the large variety of bone substitutes that have been used to fill these cystic lesions, to date there is no graft material which can be regarded as completely satisfactory, with a recurrence rate that ranges from 5-40% of treated cases. Autologous bone marrow derived mononuclear cells have been used previously to treat ABCs. Poly lactic-co-glycolic acid (PLGA) scaffolds have been used in bone tissue engineering due to their biodegradability and biocompatibility. Human platelet lysate (PL) contains a number of mitogenic growth factors and has been demonstrated to enhance mesenchymal stem cell (MSC) proliferation and expansion rate in vitro. This study is designed to assess the safety and effectiveness of using PLGA scaffolds seeded with autologous bone marrow MSCs and supplemented with osteogenic media and platelet lysate in healing bone lesions of patients suffering from aneurysmal bone cysts. This study will be conducted at the Cell Therapy Center (CTC), Jordan. Four ABC cases will be included. Patients qualified for this study are those diagnosed with ABCs and failed to be treated with other forms of classical therapies; such as allografts or who are not candidate of autografts.
Sophia Al-Adwan is the lead sponsor of 6 studies on the registry; none are open to participants now.
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Exclusion Criteria:
The lesion will be treated with curettage then 1 million of bone marrow derived MSC seeded on 5x5 mm2 PLGA scaffold will be engrafted in the cyst of ABC patient.
Biological: MSC-PLGA
Bone marrow derived MSC seeded on biodegradable PLGA, supplemented with PL.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]) as a result of the MSC-PLGA engraftment
The safety of the engraftment will be monitored by assessing any adverse event resulting from the engraftment procedure
Time frame: 3 months
Effectiveness of using PLGA scaffolds seeded with autologous bone marrow MSCs by Radiograph
Patients will be followed up radiographically to evaluate bone filling at the site of the ABC
Time frame: 6 months
Plan to share: Undecided
No publications or documents are linked to this record.
Started May 2018 (actual). Primary completion is estimated for Dec 2019, 19 months after the start.
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This study is status unknown, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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Bone Cysts, Aneurysmal
Sophia Al-Adwan