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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Mohamed Shazly, M.D contact

01006667095

elshazly@aun.edu.eg

Ahmed Tohamy, M.D contact

01002660832

ahmedtohamy92@gmail.com

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

  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 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.

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 groups in NCT03686449
Study groupRoleWhat they receive
study group 1ExperimentalNon-cultured Autologous Keratinocyte Suspension
Receives: Procedure: Non-cultured Autologous Keratinocyte Suspension
study group 2ExperimentalAdipose-Derived Stem cell-Keratinocyte Suspension
Receives: Procedure: Adipose-Derived Stem cell-Keratinocyte Suspension
Control groupActive comparatorSplit skin graft
Receives: Procedure: Split skin graft

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Length of the operating procedure

    Measured: 1 day

Secondary outcomes (1)
  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.

  1. First posted27 Sep 2018
  2. Study start1 Nov 2020 (estimated)
  3. Primary completion31 Dec 2020 (estimated)
  4. Study completion31 May 2021 (estimated)

Resources

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)
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 23598383
  • Osler 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 20038856
  • Deitch EA, Wheelahan TM, Rose MP, Clothier J, Cotter J. Hypertrophic burn scars: analysis of variables. J Trauma. 1983 Oct;23(10):895-8.

    PubMed 6632013
  • Hefton 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 6135914
  • Fraulin 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 9710733
  • Hunyadi 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 2447135
  • Behr 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 20555302
  • Garg 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 25038246
  • Kirana 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 22284892
  • Caplan 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 16619257
  • Badiavas 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 12707099
  • Hu 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 24761362
  • Zuk 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 12475952
  • Boquest 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

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.

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