NCT02672280

Brief Summary

The purpose of the present study is to evaluate the safety and exploratory efficacy of the medical collagen membrane with umbilical cord derived mesenchymal stem cells in the treatment of patients with skin defects.

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
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started May 2016

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

January 31, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 3, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

February 3, 2016

Status Verified

January 1, 2016

Enrollment Period

1.6 years

First QC Date

January 31, 2016

Last Update Submit

January 31, 2016

Conditions

WoundsDiabetic Foot UlcersBurns

Outcome Measures

Primary Outcomes (2)

  • Incidence of adverse events that are related to study treatment and associated with the grafting site

    Up to Month 36 after the last grafting day

  • Percentage of wound closure as determined

    Up to Month 3 after the last grafting day

Secondary Outcomes (7)

  • Scar outcome assessment

    Up to Month 36 after the last grafting day

  • Incidence of contracture release or revision surgeries

    Up to Month 36 after the last grafting day

  • Incidence of increased temperature sensitivity

    Up to Month 36 after the last grafting day

  • Incidence of paresthesias, pain, dulling of sensation assessed

    Up to Month 36 after the last grafting day

  • Incidence and severity of infections at grafting sites

    Up to Month 6 after the last grafting day

  • +2 more secondary outcomes

Study Arms (2)

Medical Collagen Membrane with MSC

EXPERIMENTAL

Applications of medical collagen membrane with umbilical cord derived mesenchymal stem cells (MSC).

Device: Medical Collagen Membrane with MSC

Medical Collagen Membrane

ACTIVE COMPARATOR

Application of medical collagen membrane only.

Device: Medical Collagen Membrane

Interventions

Medical Collagen Membrane with MSCDEVICE
Medical Collagen Membrane with MSC
Medical Collagen MembraneDEVICE
Medical Collagen Membrane

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18 and 70, borh gender.
  • Patient able and willing to sign informed consent and comply with study procedures.
  • Women of childbearing potential must use birth control pills, barriers or abstinence and have a negative pregnancy test.
  • Deep partial or full thickness skin defect of at least 9 cm2 requiring surgical wound coverage due to: burn injury, diabetic foot ulcer or wounds caused by mechanical damage or iatrogenic injury.

You may not qualify if:

  • Patient refusal.
  • Patient has a documented history of allergy or sensitivity to any of the animal products used in preparation of skin substitute. These products include bovine blood, bovine collagen, and bovine collagenase.
  • Patient has a documented history of allergy or sensitivity to any of the antimicrobials or reagents used in preparation and application of skin substitute including the irrigation solution used before and after grafting.
  • Patient has a current diagnosis of an invasive burn wound infection in unexcised burn wound.
  • Patient has tunnels or sinus tracts that cannot be completely debrided.
  • Serious primary diseases of the liver, kidney and hematopoietic system, Abnormal liver function(glutamic-pyruvic transaminase(ALT), glutamicoxalacetic transaminase (AST) is 2 times higher than the normal value), creatinine(Cr) is higher than the upper limit of the normal value.
  • Other clinical trial participants within 3 months.
  • A random blood sugar reading \>/=450 mg/dL.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • He L, Nan X, Wang Y, Guan L, Bai C, Shi S, Yuan H, Chen L, Liu D, Pei X. Full-thickness tissue engineered skin constructed with autogenic bone marrow mesenchymal stem cells. Sci China C Life Sci. 2007 Aug;50(4):429-37. doi: 10.1007/s11427-007-0069-2.

    PMID: 17653662BACKGROUND

Related Links

MeSH Terms

Conditions

Wounds and InjuriesDiabetic FootBurns

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesDiabetic Neuropathies

Central Study Contacts

Xuetao Pei, M.D., Ph.D

CONTACT

0086-10-68164807peixuetao@scrm.org.cn

Bowen Zhang, Ph.D

CONTACT

0086-10-66931947zhangbowen@scrm.org.cn

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2016

First Posted

February 3, 2016

Study Start

May 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

February 3, 2016

Record last verified: 2016-01