A Phase 1/2 interventional study of Implantation of allogeneic MSCs on burn wounds in Burn Wound and Second- or Third-degree Burn, sponsored by Instituto Venezolano de Investigaciones Cientificas. Enrolling by invitation at 1 site in Venezuela. Open to participants aged 2 Weeks to 85 Years. Per ClinicalTrials.gov, last updated 2023-10-26.
Sponsored by Instituto Venezolano de Investigaciones Cientificas · Phase 1/2, Interventional, and Treatment
The goal of this study is to evaluate the capacity of allogenic mesenchymal stromal cells form bone marrow (BM-MSC) or adipose tissue(Ad-MSC) to induce wound healing in patients with burn wounds.
Based on the paracrine and immunomodulatory effects of MSCs, they are considered promising cells for tissue engineering and skin regeneration in burn wounds. This protocol is designed to evaluate the efficacy of transplantation of allogenic BM-MSCs or Ad-MSCs, included in preclotted platelet-rich plasma (PRP), in patients with deep- or full-thickness burns (second- or third-degree / AB B or B degree). All patients will receive concomitant first-line treatments.
905 studies on the registry are indexed under Burns; 164 are open to participants now.
This study's planned enrollment of 50 is above the median of 40 across 663 interventional studies indexed under Burns.
Browse Burns 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.
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.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
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.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All Patients will receive conservative treatment before transplantation of allogenic MSCs embedded in autologous platelet rich plasma clot.
Biological: Implantation of allogeneic MSCs on burn wounds
Transplantation of allogeneic MSCs in patients with deep- or full-thickness burns. Allogeneic MSCs embedded in autologous platelet rich plasma clot (PRP) are implanted onto the burned areas. The treated areas will be covered with conventional dressings and burned roll. Dressings will be changed after 5 days and then weekly. The total number of MSCs used in each patient varied according to the burn injury. In patients with larger burned areas, its necessary to apply new treatments with MSCs in affected areas, at intervals of at least 1 month. Implantation will be performed in the operating room. Patients will receive first line treatments.
Also known as: Transplantation of MSCs on burn wounds
Re-epithelialization areas
Re-epithelialization will be determined by clinical evaluations and recorded by digital color photographs
Time frame: Up to 6 month
Complete burn wound healing
Time (days) to complete re-epithelialization of burned skin. It will be based on clinical evaluations and digital color photographs
Time frame: Up to 12 month
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Instituto Venezolano de Investigaciones Cientificas