Burn With Full-Thickness Skin LossNCT03686449
Autologous Keratinocyte Suspension Versus Adipose-Derived Stem Cell-Keratinocyte Suspension for Post-Burn Raw Area
A study testing Non-cultured Autologous Keratinocyte Suspension, Adipose-Derived Stem cell-Keratinocyte Suspension and Split skin graft in people with Burn With Full-Thickness Skin Loss, run by Assiut University.
Trial summary
In this study 1. Assess the efficiency of non-cultured autologous keratinocyte suspension in treating post-burn raw area. 2. Compare the results of keratinocyte suspension alone versus Adipose-derived mesenchymal stem cells-keratinocyte suspension in post-burn raw area. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burn With Full-Thickness Skin Loss
- What is being tested?
- Non-cultured Autologous Keratinocyte Suspension, Adipose-Derived Stem cell-Keratinocyte Suspension and Split skin graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2020to 31 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Post-burn raw area more than 10% total body surface area
Who cannot join
- Presence of pre-existing local and systemic bacterial infections.
- Pre-existing medical conditions that would interfere with wound healing (i.e. uncontrolled diabetes mellitus, malignancy, congestive heart failure, autoimmune disease, renal failure, corticosteroids and immunosuppressive drugs).
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Non-cultured Autologous Keratinocyte Suspension Versus Adipose-Derived Stem Cell-Keratinocyte Suspension for Coverage of Post-Burn Raw Area: A Comparative Clinical Study
In this study
- Assess the efficiency of non-cultured autologous keratinocyte suspension in treating post-burn raw area.
- Compare the results of keratinocyte suspension alone versus Adipose-derived mesenchymal stem cells-keratinocyte suspension in post-burn raw area.
Read the detailed description
Burn injuries are complicated wounds to manage with a relative high mortality rate in especially large area burns and elderly patients.
Substantial tissue damage and extensive fluid loss can cause impaired vital functions of the skin. When healing is delayed, the potential short term common complications include wound infection affecting the local healing process or systemic inflammatory and immunological responses which subsequently can cause life threatening sepsis and multi-organ failure.
Fortunately, survival rates have improved drastically over the last century due to advancements in burn care such as early surgical intervention, critical care support and wound care.
For many years the "gold standard" for treating wounds of burn patients has been transplantation with an autologous split skin graft. In patients with extensive burn wounds donor sites may be limited. In order to cover all the wounds, the patients often need multiple operations and/or the skin had to be expanded as much as possible.
However, the current different expansion techniques and treatments [mesh and Meek-Wall] frequently lead to scar formation, especially in the large mesh intersites.
The rate of wound closure depends on how quickly epidermal cells migrate out of the meshed auto graft and/ or wound edges to close the wound. Accelerating re-epithelialization could potentially improve the outcome of the healing process in terms of reducing granulation tissue formation, reducing the healing time, and thereby reducing the risk of colonization and infection, as well as scar formation.
Since clinical cases were first successfully treated with cultured epithelial layers, keratinocyte sheets have become an important tool in burn wound treatment. However, the clinical application can be limited by long culture time and fragility of the keratinocyte sheets. There is, therefore, a clinical demand for other options to cover large areas of burn wounds in the absence of viable donor sites.
A novel concept consists of treating wounds with epithelial cell suspensions. In 1998, Fraulin et al. developed a method of spreading cell suspension on to wounds using an aerosol spray in a porcine model.
The use of non-cultured keratinocyte suspensions was first reported by Hunyadi et al., showing that a group of patients with burn wounds or chronic leg ulcers, treated with a fibrin matrix containing keratinocytes, healed completely, as opposed to the control group.
In porcine wound models, non-cultured keratinocyte suspensions have been shown to accelerate wound healing, improve quality of epithelialization, and restore melanocyte population, compared to the respective control group.
Major advantages in the use of non-cultured cell suspensions are a drastic reduction of preparation time and possibly easier handling compared to keratinocyte sheets. Particularly, scar quality may be improved by enhancing the speed of epithelialization and fading of mesh patterns in split skin grafts.
On the other hand, stem cell-based therapies have gained interest as a promising approach to enhance tissue regeneration.
Stem cells are characterized by their multipotency and capacity for self-renewal. Their therapeutic potential is largely due to their ability to secrete proregenerative cytokines, making them an attractive option for the treatment of chronic wounds.
Stem cells from numerous sources are currently being tested in preclinical and clinical trials for their ability to faster wound healing and tissue regeneration. These trials have not only proven autologous stem cell therapy to be safely tolerated, but also demonstrated positive clinical outcomes.
According to the International Society of Cellular Therapy, mesenchymal stem cells are defined by their ability to adhere to a plastic surface, by their expression of the surface markers CD73, CD90, and CD105, by their lack of expression of hematopoietic markers CD14, CD34, CD45, CD11b/CD79, and CD19/HLA-DR, and by their ability to differentiate along osteoblastic, adipocytic and chondrocytic pathways.
Isolated from tissues including bone marrow, adipose tissue, umbilical cord blood, nerve tissue, and dermis, MSCs have been administered both systemically and locally for the treatment of cutaneous wounds.18 Although mesenchymal stem cells have been shown to exhibit low levels of long-term incorporation into healing wounds, a growing body of research suggests that their therapeutic benefit is attributed to their release of trophic mediators, rather than a direct structural contribution.19 Through the release of vascular endothelial growth factor, stromal cell-derived factor-1, epidermal growth factor, keratinocyte growth factor, insulin-like growth factor, and matrix metalloproteinase-9, mesenchymal stem cells promote new vessel formation, recruit endogenous progenitor cells, and direct cell differentiation, proliferation, and extracellular matrix formation during wound repair.
Mesenchymal stem cells also exhibit key immunomodulatory properties though the secretion of interferon-λ, tumor necrosis factor-α, interleukin-1α and interleukin-1β, as well as through the activation of inducible nitric oxide synthase. Mesenchymal stem cells secretion of prostaglandin E2 further regulates fibrosis and inflammation, promoting tissue healing with reduced scarring.
Finally, Mesenchymal stem cells display bactericidal properties through the secretion of antimicrobial factors and by upregulating bacterial killing and phagocytosis by immune cells.
Adipose-derived mesenchymal stem cells are a pluripotent, heterogeneous population of cells present within human adipose tissue.
However, isolation of adipose-derived mesenchymal stem cells is readily accomplished using liposuction aspirates or excised fat samples, which are obtainable with minimal donor morbidity.
Adipose-derived mesenchymal stem cells can be differentiated into adipogenic, chondrogenic, myogenic, and osteogenic cell lineages in response to specific stimuli. Alternatively, adipose-derived mesenchymal stem cells may be immediately administered without in vitro expansion or differentiation in culture.
The extraordinarily high cell yield from lipoaspirate (as many as 1*107 cells from 300 ml of lipoaspirate with at least 95% purity), as compared with bone marrow aspiration, makes Adipose-derived mesenchymal stem cells a particularly attractive cell source for the acute wound setting.
- Conditions
- Burn With Full-Thickness Skin Loss
- Being tested
- Non-cultured Autologous Keratinocyte Suspension, Adipose-Derived Stem cell-Keratinocyte Suspension, Split skin graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-cultured Autologous Keratinocyte SuspensionProcedure or surgery
New method for treatment of post-burn raw area
Adipose-Derived Stem cell-Keratinocyte SuspensionProcedure or surgery
New method for treatment of post-burn raw area
Split skin graftProcedure or surgery
Traditional method for treatment of post-burn raw area
| Study group | Role | What they receive |
|---|---|---|
| study group 1 | Experimental | Non-cultured Autologous Keratinocyte Suspension Receives: Procedure: Non-cultured Autologous Keratinocyte Suspension |
| study group 2 | Experimental | Adipose-Derived Stem cell-Keratinocyte Suspension Receives: Procedure: Adipose-Derived Stem cell-Keratinocyte Suspension |
| Control group | Active comparator | Split skin graft Receives: Procedure: Split skin graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of the operating procedure
Measured: 1 day
Secondary outcomes (1)
The mean time to 95% healing of the burn wound
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2018
- Study start1 Nov 2020 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion31 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Burn With Full-Thickness Skin LossStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Diefy Salem, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03686449
- Sponsor's protocol ID
- NAKS-ADS
- Status last verified
- May 2020
- First submitted
- 25 Sep 2018
- Last updated
- 12 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jackson PC, Hardwicke J, Bamford A, Nightingale P, Wilson Y, Papini R, Moiemen N. Revised estimates of mortality from the Birmingham Burn Centre, 2001-2010: a continuing analysis over 65 years. Ann Surg. 2014 May;259(5):979-84. doi: 10.1097/SLA.0b013e31829160ca.
PubMed 23598383Osler T, Glance LG, Hosmer DW. Simplified estimates of the probability of death after burn injuries: extending and updating the baux score. J Trauma. 2010 Mar;68(3):690-7. doi: 10.1097/TA.0b013e3181c453b3.
PubMed 20038856Deitch EA, Wheelahan TM, Rose MP, Clothier J, Cotter J. Hypertrophic burn scars: analysis of variables. J Trauma. 1983 Oct;23(10):895-8.
PubMed 6632013Hefton JM, Madden MR, Finkelstein JL, Shires GT. Grafting of burn patients with allografts of cultured epidermal cells. Lancet. 1983 Aug 20;2(8347):428-30. doi: 10.1016/s0140-6736(83)90392-6.
PubMed 6135914Fraulin FO, Bahoric A, Harrop AR, Hiruki T, Clarke HM. Autotransplantation of epithelial cells in the pig via an aerosol vehicle. J Burn Care Rehabil. 1998 Jul-Aug;19(4):337-45. doi: 10.1097/00004630-199807000-00012.
PubMed 9710733Hunyadi J, Farkas B, Bertenyi C, Olah J, Dobozy A. Keratinocyte grafting: a new means of transplantation for full-thickness wounds. J Dermatol Surg Oncol. 1988 Jan;14(1):75-8. doi: 10.1111/j.1524-4725.1988.tb03343.x.
PubMed 2447135Behr B, Ko SH, Wong VW, Gurtner GC, Longaker MT. Stem cells. Plast Reconstr Surg. 2010 Oct;126(4):1163-1171. doi: 10.1097/PRS.0b013e3181ea42bb.
PubMed 20555302Garg RK, Rennert RC, Duscher D, Sorkin M, Kosaraju R, Auerbach LJ, Lennon J, Chung MT, Paik K, Nimpf J, Rajadas J, Longaker MT, Gurtner GC. Capillary force seeding of hydrogels for adipose-derived stem cell delivery in wounds. Stem Cells Transl Med. 2014 Sep;3(9):1079-89. doi: 10.5966/sctm.2014-0007. Epub 2014 Jul 18.
PubMed 25038246Kirana S, Stratmann B, Prante C, Prohaska W, Koerperich H, Lammers D, Gastens MH, Quast T, Negrean M, Stirban OA, Nandrean SG, Gotting C, Minartz P, Kleesiek K, Tschoepe D. Autologous stem cell therapy in the treatment of limb ischaemia induced chronic tissue ulcers of diabetic foot patients. Int J Clin Pract. 2012 Apr;66(4):384-93. doi: 10.1111/j.1742-1241.2011.02886.x. Epub 2012 Jan 27.
PubMed 22284892Caplan AI, Dennis JE. Mesenchymal stem cells as trophic mediators. J Cell Biochem. 2006 Aug 1;98(5):1076-84. doi: 10.1002/jcb.20886.
PubMed 16619257Badiavas EV, Falanga V. Treatment of chronic wounds with bone marrow-derived cells. Arch Dermatol. 2003 Apr;139(4):510-6. doi: 10.1001/archderm.139.4.510.
PubMed 12707099Hu MS, Rennert RC, McArdle A, Chung MT, Walmsley GG, Longaker MT, Lorenz HP. The Role of Stem Cells During Scarless Skin Wound Healing. Adv Wound Care (New Rochelle). 2014 Apr 1;3(4):304-314. doi: 10.1089/wound.2013.0471.
PubMed 24761362Zuk PA, Zhu M, Ashjian P, De Ugarte DA, Huang JI, Mizuno H, Alfonso ZC, Fraser JK, Benhaim P, Hedrick MH. Human adipose tissue is a source of multipotent stem cells. Mol Biol Cell. 2002 Dec;13(12):4279-95. doi: 10.1091/mbc.e02-02-0105.
PubMed 12475952Boquest AC, Shahdadfar A, Brinchmann JE, Collas P. Isolation of stromal stem cells from human adipose tissue. Methods Mol Biol. 2006;325:35-46. doi: 10.1385/1-59745-005-7:35.
PubMed 16761717
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-cultured Autologous Keratinocyte Suspension Versus Adipose-Derived Stem Cell-Keratinocyte Suspension for Coverage of Post-Burn Raw Area: A Comparative Clinical Study
- ClinicalTrials.gov ID
- NCT03686449
- Acronym / sponsor ID
- NAKS-ADS
- Conditions
- Burn With Full-Thickness Skin Loss
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2020 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 May 2021 (estimated)
- First posted
- 27 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study
- Assess the efficiency of non-cultured autologous keratinocyte suspension in treating post-burn raw area.
- Compare the results of keratinocyte suspension alone versus Adipose-derived mesenchymal stem cells-keratinocyte suspension in post-burn raw area.
Detailed description
Burn injuries are complicated wounds to manage with a relative high mortality rate in especially large area burns and elderly patients.
Substantial tissue damage and extensive fluid loss can cause impaired vital functions of the skin. When healing is delayed, the potential short term common complications include wound infection affecting the local healing process or systemic inflammatory and immunological responses which subsequently can cause life threatening sepsis and multi-organ failure.
Fortunately, survival rates have improved drastically over the last century due to advancements in burn care such as early surgical intervention, critical care support and wound care.
For many years the "gold standard" for treating wounds of burn patients has been transplantation with an autologous split skin graft. In patients with extensive burn wounds donor sites may be limited. In order to cover all the wounds, the patients often need multiple operations and/or the skin had to be expanded as much as possible.
However, the current different expansion techniques and treatments [mesh and Meek-Wall] frequently lead to scar formation, especially in the large mesh intersites.
The rate of wound closure depends on how quickly epidermal cells migrate out of the meshed auto graft and/ or wound edges to close the wound. Accelerating re-epithelialization could potentially improve the outcome of the healing process in terms of reducing granulation tissue formation, reducing the healing time, and thereby reducing the risk of colonization and infection, as well as scar formation.
Since clinical cases were first successfully treated with cultured epithelial layers, keratinocyte sheets have become an important tool in burn wound treatment. However, the clinical application can be limited by long culture time and fragility of the keratinocyte sheets. There is, therefore, a clinical demand for other options to cover large areas of burn wounds in the absence of viable donor sites.
A novel concept consists of treating wounds with epithelial cell suspensions. In 1998, Fraulin et al. developed a method of spreading cell suspension on to wounds using an aerosol spray in a porcine model.
The use of non-cultured keratinocyte suspensions was first reported by Hunyadi et al., showing that a group of patients with burn wounds or chronic leg ulcers, treated with a fibrin matrix containing keratinocytes, healed completely, as opposed to the control group.
In porcine wound models, non-cultured keratinocyte suspensions have been shown to accelerate wound healing, improve quality of epithelialization, and restore melanocyte population, compared to the respective control group.
Major advantages in the use of non-cultured cell suspensions are a drastic reduction of preparation time and possibly easier handling compared to keratinocyte sheets. Particularly, scar quality may be improved by enhancing the speed of epithelialization and fading of mesh patterns in split skin grafts.
On the other hand, stem cell-based therapies have gained interest as a promising approach to enhance tissue regeneration.
Stem cells are characterized by their multipotency and capacity for self-renewal. Their therapeutic potential is largely due to their ability to secrete proregenerative cytokines, making them an attractive option for the treatment of chronic wounds.
Stem cells from numerous sources are currently being tested in preclinical and clinical trials for their ability to faster wound healing and tissue regeneration. These trials have not only proven autologous stem cell therapy to be safely tolerated, but also demonstrated positive clinical outcomes.
According to the International Society of Cellular Therapy, mesenchymal stem cells are defined by their ability to adhere to a plastic surface, by their expression of the surface markers CD73, CD90, and CD105, by their lack of expression of hematopoietic markers CD14, CD34, CD45, CD11b/CD79, and CD19/HLA-DR, and by their ability to differentiate along osteoblastic, adipocytic and chondrocytic pathways.
Isolated from tissues including bone marrow, adipose tissue, umbilical cord blood, nerve tissue, and dermis, MSCs have been administered both systemically and locally for the treatment of cutaneous wounds.18 Although mesenchymal stem cells have been shown to exhibit low levels of long-term incorporation into healing wounds, a growing body of research suggests that their therapeutic benefit is attributed to their release of trophic mediators, rather than a direct structural contribution.19 Through the release of vascular endothelial growth factor, stromal cell-derived factor-1, epidermal growth factor, keratinocyte growth factor, insulin-like growth factor, and matrix metalloproteinase-9, mesenchymal stem cells promote new vessel formation, recruit endogenous progenitor cells, and direct cell differentiation, proliferation, and extracellular matrix formation during wound repair.
Mesenchymal stem cells also exhibit key immunomodulatory properties though the secretion of interferon-λ, tumor necrosis factor-α, interleukin-1α and interleukin-1β, as well as through the activation of inducible nitric oxide synthase. Mesenchymal stem cells secretion of prostaglandin E2 further regulates fibrosis and inflammation, promoting tissue healing with reduced scarring.
Finally, Mesenchymal stem cells display bactericidal properties through the secretion of antimicrobial factors and by upregulating bacterial killing and phagocytosis by immune cells.
Adipose-derived mesenchymal stem cells are a pluripotent, heterogeneous population of cells present within human adipose tissue.
However, isolation of adipose-derived mesenchymal stem cells is readily accomplished using liposuction aspirates or excised fat samples, which are obtainable with minimal donor morbidity.
Adipose-derived mesenchymal stem cells can be differentiated into adipogenic, chondrogenic, myogenic, and osteogenic cell lineages in response to specific stimuli. Alternatively, adipose-derived mesenchymal stem cells may be immediately administered without in vitro expansion or differentiation in culture.
The extraordinarily high cell yield from lipoaspirate (as many as 1*107 cells from 300 ml of lipoaspirate with at least 95% purity), as compared with bone marrow aspiration, makes Adipose-derived mesenchymal stem cells a particularly attractive cell source for the acute wound setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| study group 1 | Experimental | Procedure: Non-cultured Autologous Keratinocyte SuspensionNon-cultured Autologous Keratinocyte Suspension |
| study group 2 | Experimental | Procedure: Adipose-Derived Stem cell-Keratinocyte SuspensionAdipose-Derived Stem cell-Keratinocyte Suspension |
| Control group | Active comparator | Procedure: Split skin graftSplit skin graft |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Post-burn raw area more than 10% total body surface area
Key exclusion criteria (2 listed)
- Presence of pre-existing local and systemic bacterial infections.
- Pre-existing medical conditions that would interfere with wound healing (i.e. uncontrolled diabetes mellitus, malignancy, congestive heart failure, autoimmune disease, renal failure, corticosteroids and immunosuppressive drugs).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-cultured Autologous Keratinocyte SuspensionNew method for treatment of post-burn raw area | Procedure or surgery | study group 1 |
| Adipose-Derived Stem cell-Keratinocyte SuspensionNew method for treatment of post-burn raw area | Procedure or surgery | study group 2 |
| Split skin graftTraditional method for treatment of post-burn raw area | Procedure or surgery | Control group |
Primary outcome
Length of the operating procedure
Time frame: 1 day
1 secondary outcome
The mean time to 95% healing of the burn wound
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2020.
- Background: PubMed 23598383Jackson PC, Hardwicke J, Bamford A, Nightingale P, Wilson Y, Papini R, Moiemen N. Revised estimates of mortality from the Birmingham Burn Centre, 2001-2010: a continuing analysis over 65 years. Ann Surg. 2014 May;259(5):979-84. doi: 10.1097/SLA.0b013e31829160ca.
- Background: PubMed 20038856Osler T, Glance LG, Hosmer DW. Simplified estimates of the probability of death after burn injuries: extending and updating the baux score. J Trauma. 2010 Mar;68(3):690-7. doi: 10.1097/TA.0b013e3181c453b3.
- Background: PubMed 6632013Deitch EA, Wheelahan TM, Rose MP, Clothier J, Cotter J. Hypertrophic burn scars: analysis of variables. J Trauma. 1983 Oct;23(10):895-8.
- Background: PubMed 6135914Hefton JM, Madden MR, Finkelstein JL, Shires GT. Grafting of burn patients with allografts of cultured epidermal cells. Lancet. 1983 Aug 20;2(8347):428-30. doi: 10.1016/s0140-6736(83)90392-6.
- Background: PubMed 9710733Fraulin FO, Bahoric A, Harrop AR, Hiruki T, Clarke HM. Autotransplantation of epithelial cells in the pig via an aerosol vehicle. J Burn Care Rehabil. 1998 Jul-Aug;19(4):337-45. doi: 10.1097/00004630-199807000-00012.
- Background: PubMed 2447135Hunyadi J, Farkas B, Bertenyi C, Olah J, Dobozy A. Keratinocyte grafting: a new means of transplantation for full-thickness wounds. J Dermatol Surg Oncol. 1988 Jan;14(1):75-8. doi: 10.1111/j.1524-4725.1988.tb03343.x.
- Background: PubMed 20555302Behr B, Ko SH, Wong VW, Gurtner GC, Longaker MT. Stem cells. Plast Reconstr Surg. 2010 Oct;126(4):1163-1171. doi: 10.1097/PRS.0b013e3181ea42bb.
- Background: PubMed 25038246Garg RK, Rennert RC, Duscher D, Sorkin M, Kosaraju R, Auerbach LJ, Lennon J, Chung MT, Paik K, Nimpf J, Rajadas J, Longaker MT, Gurtner GC. Capillary force seeding of hydrogels for adipose-derived stem cell delivery in wounds. Stem Cells Transl Med. 2014 Sep;3(9):1079-89. doi: 10.5966/sctm.2014-0007. Epub 2014 Jul 18.
- Background: PubMed 22284892Kirana S, Stratmann B, Prante C, Prohaska W, Koerperich H, Lammers D, Gastens MH, Quast T, Negrean M, Stirban OA, Nandrean SG, Gotting C, Minartz P, Kleesiek K, Tschoepe D. Autologous stem cell therapy in the treatment of limb ischaemia induced chronic tissue ulcers of diabetic foot patients. Int J Clin Pract. 2012 Apr;66(4):384-93. doi: 10.1111/j.1742-1241.2011.02886.x. Epub 2012 Jan 27.
- Background: PubMed 16619257Caplan AI, Dennis JE. Mesenchymal stem cells as trophic mediators. J Cell Biochem. 2006 Aug 1;98(5):1076-84. doi: 10.1002/jcb.20886.
- Background: PubMed 12707099Badiavas EV, Falanga V. Treatment of chronic wounds with bone marrow-derived cells. Arch Dermatol. 2003 Apr;139(4):510-6. doi: 10.1001/archderm.139.4.510.
- Background: PubMed 24761362Hu MS, Rennert RC, McArdle A, Chung MT, Walmsley GG, Longaker MT, Lorenz HP. The Role of Stem Cells During Scarless Skin Wound Healing. Adv Wound Care (New Rochelle). 2014 Apr 1;3(4):304-314. doi: 10.1089/wound.2013.0471.
- Individual participant dataSharing planned: No
Related trials for Burn With Full-Thickness Skin Loss
Not yet recruitingObservational study
The Use of Cultured (Dermal) Epithelial Autografts in Severely Burned Patients
Burn Degree Second, Burn Degree Third
RecruitingPhase 1/2
HUMSCs Combined With Col I to Third-Degree Burn Wound
Burn Wounds, Third-Degree Burn Wounds
RecruitingPhase 3
Safety and Efficacy of realSKIN® to Provide Complete Wound Closure of Burn Wounds as an Alternative to Autografting
Burns Degree Third, Burn (Disorder)
RecruitingPhase 4
Microsurfaced Grafts in Deep Burn Wounds
Burns, Wound Heal
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Non-cultured Autologous Keratinocyte Suspension, Adipose-Derived Stem cell-Keratinocyte Suspension and Split skin graft in people with Burn With Full-Thickness Skin Loss, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 May 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Shazly, M.D (01006667095, elshazly@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of the operating procedure (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03686449, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2020.