Mesenchymal Stem Cell-derived Pleiotropic Factor in Treating Non-healing Wounds
Primary Purpose
Mesenchymal Stem Cell-derived Bioactivator for Treating Chronic Wounds
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Stem cell-derived derived pleiotropic factor
fibroblast growth factor
Sponsored by
About this trial
This is an interventional treatment trial for Mesenchymal Stem Cell-derived Bioactivator for Treating Chronic Wounds
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of chronic wounds; Male or female over 17; Psychologically stable and able to complete the experimental process. -
Exclusion Criteria:
wound greater than 10cm ×10cm; Exposure to radiation or use of hormones, chemotherapy, growth factor dressings and immunosuppressants within 3 months; Participated in other similar tests within 3 months; Pregnant, or lactating women; Severe infectious disease; Severe heart, liver, and kidney dysfunction; Had a history of cancer -
Sites / Locations
- Chinese PLA General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
control group
experimental group
Arm Description
Outcomes
Primary Outcome Measures
wound healing rate
Original wound area minus unhealed wound area then divided by original wound area
Secondary Outcome Measures
Full Information
NCT ID
NCT04235868
First Posted
January 16, 2020
Last Updated
May 9, 2020
Sponsor
Chinese PLA General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04235868
Brief Title
Mesenchymal Stem Cell-derived Pleiotropic Factor in Treating Non-healing Wounds
Official Title
Clinical Trial of Mesenchymal Stem Cell-derived Pleiotropic Factor in Treating Non-healing Wounds
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 20, 2019 (Actual)
Primary Completion Date
August 30, 2020 (Anticipated)
Study Completion Date
October 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese PLA General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Chronic wounds do not heal for prolonged periods of time with the significant financial burden on the healthcare system. It has become increasingly essential to improve our clinical treatments. The most promising potential treatment options rely on stem cell-based therapies. A large body of evidence indicates that mesenchymal stem cells can promote wound closure of chronic wounds in animal models and in preclinical studies. MSCs efficacy depends mostly on their paracrine activity. All the bioactive factors and cytokines in MSCs secretions constitute can be collected in the conditioned medium. In here, stem cell-derived conditioned medium was further made into a lyophilized powder. Patients with chronic wounds were enrolled. The wounds in control group treated with fibroblast growth factor commonly used in clinical practice. The wounds in experimental group treated with lyophilized powder. The effectiveness and safety of lyophilized powder will evaluate for chronic wounds.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mesenchymal Stem Cell-derived Bioactivator for Treating Chronic Wounds
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
control group
Arm Type
Active Comparator
Arm Title
experimental group
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Stem cell-derived derived pleiotropic factor
Intervention Description
After debridement, the wounds in experimental group apply stem cell-derived lyophilized powder, and use foam dressing to wrap the wound; apply once every 2-3 days.
Intervention Type
Biological
Intervention Name(s)
fibroblast growth factor
Intervention Description
After debridement, the wounds in control group apply fibroblast growth factor to the wound surface, and use foam dressing to wrap the wound; apply once every 2-3 days.
Primary Outcome Measure Information:
Title
wound healing rate
Description
Original wound area minus unhealed wound area then divided by original wound area
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of chronic wounds; Male or female over 17; Psychologically stable and able to complete the experimental process. -
Exclusion Criteria:
wound greater than 10cm ×10cm; Exposure to radiation or use of hormones, chemotherapy, growth factor dressings and immunosuppressants within 3 months; Participated in other similar tests within 3 months; Pregnant, or lactating women; Severe infectious disease; Severe heart, liver, and kidney dysfunction; Had a history of cancer -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Meirong Li, doctor
Phone
010-66936345
Email
meirong811225@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaobing Fu, doctor
Organizational Affiliation
Chinese PLA General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chinese PLA General Hospital
City
Beijing
ZIP/Postal Code
100853
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meirong Li, doctor
Phone
01066936345
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Need to contact the researcher and open sharing after the researcher's consent
IPD Sharing Time Frame
One year after the experiment
IPD Sharing Access Criteria
The way of sharing IPD has not yet been determined
Learn more about this trial
Mesenchymal Stem Cell-derived Pleiotropic Factor in Treating Non-healing Wounds
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