Mesenchymal Stem Cell-derived Bioactivator for Treating Chronic WoundsPhase 1NCT04235868
Mesenchymal Stem Cell-derived Pleiotropic Factor in Treating Non-healing Wounds
A Phase 1 study testing Stem cell-derived derived pleiotropic factor and fibroblast growth factor in people with Mesenchymal Stem Cell-derived Bioactivator for Treating Chronic Wounds, run by Chinese PLA General Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Mesenchymal Stem Cell-derived Bioactivator for Treating Chronic Wounds
- What is being tested?
- Stem cell-derived derived pleiotropic factor and fibroblast growth factor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 20 Oct 2019to 30 Oct 2020
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of chronic wounds; Male or female over 17; Psychologically stable and able to complete the experimental process. -
Who cannot join
- 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 -
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chinese PLA General Hospital
Beijing, 100853
Meirong Li, doctor, 01066936345
About this study
Official title: 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.
- Being tested
- Stem cell-derived derived pleiotropic factor, fibroblast growth factor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stem cell-derived derived pleiotropic factorBiological
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.
fibroblast growth factorBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | Not described Receives: Biological: fibroblast growth factor |
| experimental group | Experimental | Not described Receives: Biological: Stem cell-derived derived pleiotropic factor |
What is being measured
The primary outcome is the main question the study is designed to answer.
wound healing rate
Original wound area minus unhealed wound area then divided by original wound area
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 posted22 Jan 2020
- Study start20 Oct 2019
- Primary completion30 Aug 2020 (estimated)
- Study completion30 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mesenchymal Stem Cell-derived Bioactivator for Treating Chronic WoundsStudies of the same condition, open and under way.
- 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, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaobing Fu, Chinese PLA General Hospital
- Investigators
- Xiaobing Fu, doctor, Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04235868
- Sponsor's protocol ID
- MP-01
- Status last verified
- May 2020
- First submitted
- 16 Jan 2020
- Last updated
- 12 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Need to contact the researcher and open sharing after the researcher's consent
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of Mesenchymal Stem Cell-derived Pleiotropic Factor in Treating Non-healing Wounds
- ClinicalTrials.gov ID
- NCT04235868
- Acronym / sponsor ID
- MP-01
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 20 Oct 2019 (actual)
- Primary completion
- 30 Aug 2020 (estimated)
- Study completion
- 30 Oct 2020 (estimated)
- First posted
- 22 Jan 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Biological: fibroblast growth factor |
| experimental group | Experimental | Biological: Stem cell-derived derived pleiotropic factor |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of chronic wounds; Male or female over 17; Psychologically stable and able to complete the experimental process. -
Key exclusion criteria (1 listed)
- 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 -
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 |
|---|---|---|
| Stem cell-derived derived pleiotropic factorAfter 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. | Biological | experimental group |
| fibroblast growth factorAfter 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. | Biological | control group |
Primary outcome
wound healing rate
Time frame: 1 month
Original wound area minus unhealed wound area then divided by original wound area
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2020.
- Individual participant dataSharing planned: Yes. Need to contact the researcher and open sharing after the researcher's consent
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.
Xiaobing Fu, doctor principal investigator
Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Stem cell-derived derived pleiotropic factor and fibroblast growth factor in people with Mesenchymal Stem Cell-derived Bioactivator for Treating Chronic Wounds, run by Chinese PLA General Hospital at 1 site in China.
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 1 inclusion and 1 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 12 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 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 12 May 2020.