Mesenchymal Stem Cell-derived Pleiotropic Factor in Treating Non-healing Wounds
May 9, 2020 updated by: Xiaobing Fu, Chinese PLA General Hospital
Clinical Trial of Mesenchymal Stem Cell-derived Pleiotropic Factor in Treating Non-healing Wounds
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.
Study Overview
Status
Unknown
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Beijing, China, 100853
- Recruiting
- Chinese PLA General Hospital
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Contact:
- Meirong Li, doctor
- Phone Number: 01066936345
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 -
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: experimental group
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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.
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Active Comparator: control group
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
wound healing rate
Time Frame: 1 month
|
Original wound area minus unhealed wound area then divided by original wound area
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Xiaobing Fu, doctor, Chinese PLA General Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 20, 2019
Primary Completion (Anticipated)
August 30, 2020
Study Completion (Anticipated)
October 30, 2020
Study Registration Dates
First Submitted
January 16, 2020
First Submitted That Met QC Criteria
January 18, 2020
First Posted (Actual)
January 22, 2020
Study Record Updates
Last Update Posted (Actual)
May 12, 2020
Last Update Submitted That Met QC Criteria
May 9, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MP-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD 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
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.