A Phase 1/2 interventional study of Transplantation of allogeneic MSCs in periodontal disease in Chronic Periodontal Disease and Aggressive Periodontitis, sponsored by Instituto Venezolano de Investigaciones Cientificas. Enrolling by invitation at 1 site in Venezuela. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-04.
Sponsored by Instituto Venezolano de Investigaciones Cientificas · Phase 1/2, Interventional, and Treatment
The goal of this study is to evaluate the capacity of allogeneic bone marrow mesenchymal stromal cells (MSC) to induce bone regeneration in patients with periodontal disease. MSC cultured are loaded on a collagen scaffold, included into autologous platelet rich plasma clot and implanted in the bone defect.
The clinical protocol is designed to evaluate the bone regeneration capacity of allogeneic MSCs for the treatment of patients with chronic or aggressive periodontal disease. Patients with either a 2- or 3-wall intrabony defects are included in this study. A bioengineering construct, constituted by allogeneic MSCs and a collagen scaffold, is incorporated into platelet rich plasma (PRP) clot, which is implanted at the bone defect site. Follow up of treated tooth are assessed by clinical evaluation, intraoral radiography and cone-beam CT.
377 studies on the registry are indexed under Chronic Periodontitis; 21 are open to participants now.
This study's planned enrollment of 30 is below the median of 46 across 307 interventional studies indexed under Chronic Periodontitis.
Browse Chronic Periodontitis studies →Instituto Venezolano de Investigaciones Cientificas is the lead sponsor of 5 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic MSC harvested and cultured in osteogenic medium are seeded on collagen scaffold, mixed with autologous platelet rich plasma clot. The MSCs construct (MSCs/Coll/PRP clot) is implanted in the bone defect.
Biological: Transplantation of allogeneic MSCs in periodontal disease
Oral surgery is performed in patients with periodontal disease, under local anesthesia. An incision will be made on the periodontal lesion, A full-thickness flap is elevated on both the buccal and lingual areas and the inner epithelium of the flap removed. Granulation tissue is removed from bone defect area, and a root planning is performed. MSC construct is placed around the bone defect and a collagen membrane is used to cover and close off the bone defect site. The flap will be repositioned and the wound closed by a suture
Change in clinical attachment level (CAL)
Expressed as the distance in millimeters from the cemento-enamel junction (CEJ) to the bottom of the probable gingival/periodontal pocket.
Time frame: Follow-up includes evaluation at 3, 6, 9 and 12 months post-transplantation
Change in probing pocket depth (PPD)
The distance from the gingival margin to the bottom of the gingival sulcus/pocket, is measured by means of periodontal probe.
Time frame: Follow-up includes evaluation at 3, 6, 9 and 12 months post-transplantation
Gingival recession (GR)
Exposure of the tooth through apical migration of the gingiva will be recorded as the distance in millimeters from the CEJ to the gingival margin
Time frame: Follow-up includes evaluation at 3, 6, 9 and 12 months post-transplantation
Change in bone density
Changes in the density of the periodontal bone defect will be detected by Cone beam Tomography
Time frame: Follow-up includes evaluation at 3, 6, 9 and 12 months post-transplantation
Change in Tooth Mobility (TM)
Changes from baseline in tooth mobility will be recorded.
Time frame: Follow-up includes evaluation at 3, 6, 9 and 12 months post-transplantation
Change in bone depth
The vertical bone defects will be assessed by X-rays. The postoperative depth of the intrabony defect will be calculated from the distance between the cemento-enamel junction and the bone crest on the preoperative and postoperative radiographs at the same magnification.
Time frame: Follow-up includes evaluation at 3, 6, 9 and 12 months post-transplantation
Plan to share: No
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Instituto Venezolano de Investigaciones Cientificas