NCT01443689

A Phase Ι/Π Study of Human Cord Blood Mononuclear Cells and Human Umbilical Cord Mesenchymal Stem Cells Transplantation in Patients With Acute Burn

Status unknown Phase 1/Phase 2 Last updated 26 November 2012

What this trial tests

Phase 1/Phase 2 trial testing human umbilical cord mesenchymal stem cells in Burns in 20 participants. Status unknown.

Timeline

1 July 2011

Primary endpoint
1 March 2013

1 July 2013

Quick facts

Lead sponsor	Shenzhen Beike Bio-Technology Co., Ltd.
Phase	Phase 1/Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	1 July 2011
Primary completion	1 March 2013
Estimated completion	1 July 2013
Sites	1 location across China

Drugs / interventions tested

• human umbilical cord mesenchymal stem cells
• human cord blood mononuclear cells and human umbilical cord mesenchymal stem cells — full drug profile →
• Conventional therapy — full drug profile →

Conditions studied

• Burns — all drugs for Burns →

Sponsor

Shenzhen Beike Bio-Technology Co., Ltd. — full company profile →

Who can join

Adults 18 to 65, any sex, with Burns. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• The ratio of wound contraction and re-epithelialisation
  Time frame: 6 months after treatment
• Complete healing time for investigated burn area
  Time frame: 6 months after treatment
• Vancouver Scar Scale
  Time frame: 6 months after treatment

Sponsor's own description

Burn trauma,especially extensive ones, remains a life-threatening local and general inflammatory condition destroying the skin and underlying tissues, and resulting in serious sequelae. Remarkable progress has been achieved during last 30 years，stem cell therapy plays an important role in this progress. Human umbilical cord mesenchymal stem cells (hUCMSCs) and human cord blood mononuclear cells (hCBMNCs) have been shown to have the ability to modulate the immune response and enhance angiogenesis, suggesting the novel and promising therapeutic strategy for burn. In this study, the safety and efficacy of hUCMSCs and hCBMNCs transplantation will be evaluated in patients with acute burn.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Wharton's jelly derived mesenchymal stem cells: future of regenerative medicine? Recent findings and clinical significance.
   Kalaszczynska I, Ferdyn K. · · 2015 · cited 117× · PMID 25861624 · DOI 10.1155/2015/430847
2. Mesenchymal stem cells: potential for therapy and treatment of chronic non-healing skin wounds.
   Marfia G, Navone SE, Di Vito C, Ughi N, et al · · 2015 · cited 80× · PMID 26652928 · DOI 10.1080/15476278.2015.1126018
3. The role and potential of umbilical cord blood in an era of new therapies: a review.
   Roura S, Pujal JM, Gálvez-Montón C, Bayes-Genis A. · · 2015 · cited 68× · PMID 26133757 · DOI 10.1186/s13287-015-0113-2
4. Mesenchymal stem cell-based therapy for burn wound healing.
   Wang M, Xu X, Lei X, Tan J, et al · · 2021 · cited 47× · PMID 34212055 · DOI 10.1093/burnst/tkab002
5. Therapeutic Applications of Stem Cells and Extracellular Vesicles in Emergency Care: Futuristic Perspectives.
   Öztürk S, Elçin AE, Koca A, Elçin YM. · · 2021 · cited 28× · PMID 32839921 · DOI 10.1007/s12015-020-10029-2
6. The Myofibroblast Fate of Therapeutic Mesenchymal Stromal Cells: Regeneration, Repair, or Despair?
   Younesi FS, Hinz B. · · 2024 · cited 7× · PMID 39201399 · DOI 10.3390/ijms25168712
7. The use of stem cells in aesthetic dermatology and plastic surgery procedures. A compact review of experimental and clinical applications.
   Nowacki M, Kloskowski T, Pietkun K, Zegarski M, et al · · 2017 · cited 7× · PMID 29422816 · DOI 10.5114/ada.2017.72456