search
Back to results

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
Chinese PLA General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mesenchymal Stem Cell-derived Bioactivator for Treating Chronic Wounds

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
January 16, 2020
Last Updated
May 9, 2020
Sponsor
Chinese PLA General Hospital
search

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

We'll reach out to this number within 24 hrs