NCT03686449

Brief Summary

In this study

  1. 1.Assess the efficiency of non-cultured autologous keratinocyte suspension in treating post-burn raw area.
  2. 2.Compare the results of keratinocyte suspension alone versus Adipose-derived mesenchymal stem cells-keratinocyte suspension in post-burn raw area.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2020

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 27, 2018

Completed
2.1 years until next milestone

Study Start

First participant enrolled

November 1, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2021

Completed
Last Updated

May 12, 2020

Status Verified

May 1, 2020

Enrollment Period

2 months

First QC Date

September 25, 2018

Last Update Submit

May 10, 2020

Conditions

Burn With Full-Thickness Skin Loss

Outcome Measures

Primary Outcomes (1)

  • Length of the operating procedure

    1 day

Secondary Outcomes (1)

  • The mean time to 95% healing of the burn wound

    1 month

Study Arms (3)

study group 1

EXPERIMENTAL

Non-cultured Autologous Keratinocyte Suspension

Procedure: Non-cultured Autologous Keratinocyte Suspension

study group 2

EXPERIMENTAL

Adipose-Derived Stem cell-Keratinocyte Suspension

Procedure: Adipose-Derived Stem cell-Keratinocyte Suspension

Control group

ACTIVE COMPARATOR

Split skin graft

Procedure: Split skin graft

Interventions

Non-cultured Autologous Keratinocyte SuspensionPROCEDURE

New method for treatment of post-burn raw area

study group 1
Adipose-Derived Stem cell-Keratinocyte SuspensionPROCEDURE

New method for treatment of post-burn raw area

study group 2
Split skin graftPROCEDURE

Traditional method for treatment of post-burn raw area

Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Post-burn raw area more than 10% total body surface area

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (14)

  • 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.

    PMID: 23598383BACKGROUND

  • 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.

    PMID: 20038856BACKGROUND

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

    PMID: 6632013BACKGROUND

  • 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.

    PMID: 6135914BACKGROUND

  • 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.

    PMID: 9710733BACKGROUND

  • 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.

    PMID: 2447135BACKGROUND

  • 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.

    PMID: 20555302BACKGROUND

  • 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.

    PMID: 25038246BACKGROUND

  • 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.

    PMID: 22284892BACKGROUND

  • 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.

    PMID: 16619257BACKGROUND

  • 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.

    PMID: 12707099BACKGROUND

  • 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.

    PMID: 24761362BACKGROUND

  • 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.

    PMID: 12475952BACKGROUND

  • 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.

    PMID: 16761717BACKGROUND

Central Study Contacts

Mohamed Shazly, M.D

CONTACT

01006667095elshazly@aun.edu.eg

Ahmed Tohamy, M.D

CONTACT

01002660832ahmedtohamy92@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

September 25, 2018

First Posted

September 27, 2018

Study Start

November 1, 2020

Primary Completion

December 31, 2020

Study Completion

May 31, 2021

Last Updated

May 12, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share