MSCs-PFs in Treating Poorly Healed Wounds of Postoperative IncisionPhase 1NCT04538885
Mesenchymal Stem Cell-derived Pleiotropic Factor in Treating Poorly Healed Wounds of Postoperative Incision
A Phase 1 study testing The pleiotropic factor derived from mesenchymal stem cells in people with MSCs-PFs in Treating Poorly Healed Wounds of Postoperative Incision, run by Chinese PLA General Hospital.
Trial summary
Poor incision healing is a common complication after abdominal surgery, mainly manifested as incision dehiscence, subcutaneous fat liquefaction, malnutrition, and incision infection. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- MSCs-PFs in Treating Poorly Healed Wounds of Postoperative Incision
- What is being tested?
- The pleiotropic factor derived from mesenchymal stem cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 10 Sep 2020to 30 May 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Wound size <10X10cm2, the wound base only involves subcutaneous and muscle tissue；
- Underwent surgical treatment, all incisions were type I, and the incisions healed poorly and delayed healing after 1 week；
- There is inflammatory reaction at the incision, but no clear indication of infection, or severe infection of the incision.After debridement and dressing change, the infection is controlled and the fresh granulation period is entered
- Men or women older than 17 years old and younger than 75 years old;
- Psychologically stable, able to complete the test process.
Who cannot join
- Wound size>10X10cm2, the wound base is as deep as the chest and abdominal cavity, causing infection or osteomyelitis in the chest and abdominal cavity;
- Surgical incision with purulent infection, local purulent secretions can be seen;
- Those with obvious body temperature and white blood cell elevation, local purulent secretions have positive bacterial culture;
- Patients with diabetes;
- Glucocorticoid users;
- Patients with immune dermatosis;
- Neoplastic wounds, such as wounds after skin cancer resection, or skin wounds caused by tumor invasion;
- Psycho-psychological disorders and poor compliance.
Trial locations and contacts
No sites are listed yet.
About this study
Poor incision healing is a common complication after abdominal surgery, mainly manifested as incision dehiscence, subcutaneous fat liquefaction, malnutrition, and incision infection. Poor healing of the incision will increase the patient's pain and prolong the patient's hospital stay, and the choice of wound treatment is closely related to the wound healing effect. Mesenchymal stem cells mainly rely on paracrine effects to exert their therapeutic effects and obtain better therapeutic effects in wound healing. Here, the pleiotropic factors secreted from mesenchymal stem cells (MSCs-PFs) will be used to treat patients with poor healing after surgery to evaluate its effectiveness and safety.
- Being tested
- The pleiotropic factor derived from mesenchymal stem cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The pleiotropic factor derived from mesenchymal stem cellsBiological
The pleiotropic factor derived from mesenchymal stem cells was smeared on the wound with a dosage of (2.5mg/2cm2), and then the wound was covered with a foam dressing; the dressing was changed every 3 days to reach clinical healing as the end of the trial.
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | No intervention |
| experimental group | Experimental | The pleiotropic factor derived from mesenchymal stem cells was smeared on the wound with a dosage of (2.5mg/2cm2) Receives: Biological: The pleiotropic factor derived from mesenchymal stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound healing time and healing rate
Judgment criteria for incision recovery (4 weeks after treatment): Cure: the patient's incision is completely or basically healed, and the surrounding skin returns to normal; markedly effective: the patient's incision is recovered> 1/2, and the surrounding skin returns to normal; effective: the patient's incision is recovered <1 /2, and the surrounding skin returned to normal; invalid: the patient's incision had no obvious changes, and the surrounding skin color had no obvious improvement.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2020
- Study start10 Sep 2020 (estimated)
- Primary completion31 Mar 2021 (estimated)
- Study completion30 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MSCs-PFs in Treating Poorly Healed Wounds of Postoperative IncisionStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Gansu Provincial Maternal and Child Health Care Hospital
- Responsible party
- Principal investigator, Xiaobing Fu, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04538885
- Sponsor's protocol ID
- CHIN-PLAGH-MP-04
- Status last verified
- Sep 2020
- First submitted
- 30 Aug 2020
- Last updated
- 9 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: If any researcher needs it, you can apply to us
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mesenchymal Stem Cell-derived Pleiotropic Factor in Treating Poorly Healed Wounds of Postoperative Incision
- ClinicalTrials.gov ID
- NCT04538885
- Acronym / sponsor ID
- CHIN-PLAGH-MP-04
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Collaborators
- Gansu Provincial Maternal and Child Health Care Hospital
- Study start
- 10 Sep 2020 (estimated)
- Primary completion
- 31 Mar 2021 (estimated)
- Study completion
- 30 May 2021 (estimated)
- First posted
- 4 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Poor incision healing is a common complication after abdominal surgery, mainly manifested as incision dehiscence, subcutaneous fat liquefaction, malnutrition, and incision infection. Poor healing of the incision will increase the patient's pain and prolong the patient's hospital stay, and the choice of wound treatment is closely related to the wound healing effect. Mesenchymal stem cells mainly rely on paracrine effects to exert their therapeutic effects and obtain better therapeutic effects in wound healing. Here, the pleiotropic factors secreted from mesenchymal stem cells (MSCs-PFs) will be used to treat patients with poor healing after surgery to evaluate its effectiveness and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –No intervention |
| experimental group | Experimental | Biological: The pleiotropic factor derived from mesenchymal stem cellsThe pleiotropic factor derived from mesenchymal stem cells was smeared on the wound with a dosage of (2.5mg/2cm2) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Wound size <10X10cm2, the wound base only involves subcutaneous and muscle tissue；
- Underwent surgical treatment, all incisions were type I, and the incisions healed poorly and delayed healing after 1 week；
- There is inflammatory reaction at the incision, but no clear indication of infection, or severe infection of the incision.After debridement and dressing change, the infection is controlled and the fresh granulation period is entered
- Men or women older than 17 years old and younger than 75 years old;
- Psychologically stable, able to complete the test process.
Key exclusion criteria (8 listed)
- Wound size>10X10cm2, the wound base is as deep as the chest and abdominal cavity, causing infection or osteomyelitis in the chest and abdominal cavity;
- Surgical incision with purulent infection, local purulent secretions can be seen;
- Those with obvious body temperature and white blood cell elevation, local purulent secretions have positive bacterial culture;
- Patients with diabetes;
- Glucocorticoid users;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The pleiotropic factor derived from mesenchymal stem cellsThe pleiotropic factor derived from mesenchymal stem cells was smeared on the wound with a dosage of (2.5mg/2cm2), and then the wound was covered with a foam dressing; the dressing was changed every 3 days to reach clinical healing as the end of the trial. | Biological | experimental group |
Primary outcome
Wound healing time and healing rate
Time frame: 1 month
Judgment criteria for incision recovery (4 weeks after treatment): Cure: the patient's incision is completely or basically healed, and the surrounding skin returns to normal; markedly effective: the patient's incision is recovered> 1/2, and the surrounding skin returns to normal; effective: the patient's incision is recovered <1 /2, and the surrounding skin returned to normal; invalid: the patient's incision had no obvious changes, and the surrounding skin color had no obvious improvement.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
- Individual participant dataSharing planned: Undecided. If any researcher needs it, you can apply to us
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing The pleiotropic factor derived from mesenchymal stem cells in people with MSCs-PFs in Treating Poorly Healed Wounds of Postoperative Incision, run by Chinese PLA General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Meirong Li, doctor (010-66936345, meirong811225@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound healing time and healing rate (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2020.