BurnsPhase 1/2NCT01443689
Allogenic Stem Cell Therapy in Patients With Acute Burn
A Phase 1/2 study testing human umbilical cord mesenchymal stem cells, human cord blood mononuclear cells and human umbilical cord mesenchymal stem cells and Conventional therapy in people with Burns, run by Shenzhen Beike Bio-Technology Co., Ltd. at 1 site in China.
Trial summary
Burn trauma,especially extensive ones, remains a life-threatening local and general inflammatory condition destroying the skin and underlying tissues, and resulting in serious sequelae. Remarkable progress has been achieved during last 30 years，stem cell therapy plays an important role in this progress. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Burns
- What is being tested?
- human umbilical cord mesenchymal stem cells, human cord blood mononuclear cells and human umbilical cord mesenchymal stem cells and Conventional therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- Jul 2011to Jul 2013
- Phase
- Phase 1/2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between age 18- 65 years, both gender.
- Diagnosed with Acute, Moderate-Severe, full-thickness burn:
- Burn occurring within the 72 hours prior to administration. TBSA 20-55%, third degree wounds surface area < 19 % ;
- Willing to sign the Informed Consent Form.
Who cannot join
- All other burns except thermal origin.
- Chronically malnourished, poor medical condition or shock
- Systemic inflammatory response syndrome (SIRS) or septicopyemia
- Moderate-severe inhalation injury airways to lung
- HIV+
- Autoimmune disease, e.g. lupus erythematosus, multiple sclerosis.
Show all 11Show fewer
- Severe pulmonary and hematological disease, malignancy or hypo-immunity.
- Currently undertaking other treatment that may affect the safety/efficacy of stem cells.
- Pregnancy or lactation
- Enrollment in other trials in the last 3 months.
- Other criteria the investigator consider improper for inclusion.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Kunmming Medical College
Kunming, Yunnan, 650033
Jinfeng Fu, 86-871-5351281, ynfjf@hotmail.com
Jinfeng Fu
About this study
Official title: A Phase Ι/Π Study of Human Cord Blood Mononuclear Cells and Human Umbilical Cord Mesenchymal Stem Cells Transplantation in Patients With Acute Burn
Burn trauma,especially extensive ones, remains a life-threatening local and general inflammatory condition destroying the skin and underlying tissues, and resulting in serious sequelae. Remarkable progress has been achieved during last 30 years，stem cell therapy plays an important role in this progress. Human umbilical cord mesenchymal stem cells (hUCMSCs) and human cord blood mononuclear cells (hCBMNCs) have been shown to have the ability to modulate the immune response and enhance angiogenesis, suggesting the novel and promising therapeutic strategy for burn. In this study, the safety and efficacy of hUCMSCs and hCBMNCs transplantation will be evaluated in patients with acute burn.
Read the detailed description
To investigate the safety and efficacy of human cord blood mononuclear cells and human umbilical cord mesenchymal stem cells transplantation in patients of Acute, Moderate-Severe, Full-thickness burn.
- Conditions
- Burns
- Being tested
- human umbilical cord mesenchymal stem cells, human cord blood mononuclear cells and human umbilical cord mesenchymal stem cells, Conventional therapy
- Keywords
- Extensive Burn, Human Cord Blood Mononuclear Cells, Human Umbilical Cord Mesenchymal Stem Cells
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
human umbilical cord mesenchymal stem cellsBiological
Participants will be given conventional therapy plus hUCMSCs transplantation.
human cord blood mononuclear cells and human umbilical cord mesenchymal stem cellsBiological
Participants will be given conventional therapy plus and hCBMNCs and hUCMSCs transplantation.
Participants will be given conventional therapy only.
| Study group | Role | What they receive |
|---|---|---|
| Group1 :Conventional plus hUCMSCs treatment | Experimental | Participants will be given conventional therapy plus human cord mesenchymal stem cells transplantation with a 6 months follow-up. Receives: Biological: human umbilical cord mesenchymal stem cells |
| Group 2: Conventional plus hCBMNCs and hUCMSCs therapy | Experimental | Participants will be given conventional therapy plus combination of hCBMNCs together with hUCMSCs transplantation with a 6 months follow-up. Receives: Biological: human cord blood mononuclear cells and human umbilical cord mesenchymal stem cells |
| Group 3:Conventional therapy | Active comparator | Participants will be given conventional therapy only with a 6 months follow-up. Receives: Drug: Conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The ratio of wound contraction and re-epithelialisation
Measured: 6 months after treatment
Complete healing time for investigated burn area
Measured: 6 months after treatment
Vancouver Scar Scale
Measured: 6 months after treatment
Secondary outcomes (4)
Incidence of infections and bleedings in burn wounds
Measured: 6 months after treatment]
Engraftment assessment: Vitality of the graft
Measured: 6 months after treatment]
McGill pain Questionnaire
Measured: 6 months after treatment
Incidence of Adverse Events and Serious Adverse Events
Measured: 6 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2011 (estimated)
- Study startJul 2011
- Primary completionMar 2013 (estimated)
- Study completionJul 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Beike Bio-Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Second Affiliated Hospital of Kunming Medical University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01443689
- Sponsor's protocol ID
- BKCR-BURN-1.0(2011)
- Status last verified
- Nov 2012
- First submitted
- 27 Sep 2011
- Last updated
- 28 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ι/Π Study of Human Cord Blood Mononuclear Cells and Human Umbilical Cord Mesenchymal Stem Cells Transplantation in Patients With Acute Burn
- ClinicalTrials.gov ID
- NCT01443689
- Acronym / sponsor ID
- BKCR-BURN-1.0(2011)
- Conditions
- Burns
- Keywords
- Extensive Burn, Human Cord Blood Mononuclear Cells, Human Umbilical Cord Mesenchymal Stem Cells
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Shenzhen Beike Bio-Technology Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- The Second Affiliated Hospital of Kunming Medical University
- Study start
- Jul 2011
- Primary completion
- Mar 2013 (estimated)
- Study completion
- Jul 2013 (estimated)
- First posted
- 30 Sep 2011 (estimated)
- 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.
Burn trauma,especially extensive ones, remains a life-threatening local and general inflammatory condition destroying the skin and underlying tissues, and resulting in serious sequelae. Remarkable progress has been achieved during last 30 years，stem cell therapy plays an important role in this progress. Human umbilical cord mesenchymal stem cells (hUCMSCs) and human cord blood mononuclear cells (hCBMNCs) have been shown to have the ability to modulate the immune response and enhance angiogenesis, suggesting the novel and promising therapeutic strategy for burn. In this study, the safety and efficacy of hUCMSCs and hCBMNCs transplantation will be evaluated in patients with acute burn.
Detailed description
To investigate the safety and efficacy of human cord blood mononuclear cells and human umbilical cord mesenchymal stem cells transplantation in patients of Acute, Moderate-Severe, Full-thickness burn.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group1 :Conventional plus hUCMSCs treatment | Experimental | Biological: human umbilical cord mesenchymal stem cellsParticipants will be given conventional therapy plus human cord mesenchymal stem cells transplantation with a 6 months follow-up. |
| Group 2: Conventional plus hCBMNCs and hUCMSCs therapy | Experimental | Biological: human cord blood mononuclear cells and human umbilical cord mesenchymal stem cellsParticipants will be given conventional therapy plus combination of hCBMNCs together with hUCMSCs transplantation with a 6 months follow-up. |
| Group 3:Conventional therapy | Active comparator | Drug: Conventional therapyParticipants will be given conventional therapy only with a 6 months follow-up. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Between age 18- 65 years, both gender.
- Diagnosed with Acute, Moderate-Severe, full-thickness burn:
- Burn occurring within the 72 hours prior to administration. TBSA 20-55%, third degree wounds surface area < 19 % ;
- Willing to sign the Informed Consent Form.
Key exclusion criteria (11 listed)
- All other burns except thermal origin.
- Chronically malnourished, poor medical condition or shock
- Systemic inflammatory response syndrome (SIRS) or septicopyemia
- Moderate-severe inhalation injury airways to lung
- HIV+
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 |
|---|---|---|
| human umbilical cord mesenchymal stem cellsParticipants will be given conventional therapy plus hUCMSCs transplantation. | Biological | Group1 :Conventional plus hUCMSCs treatment |
| human cord blood mononuclear cells and human umbilical cord mesenchymal stem cellsParticipants will be given conventional therapy plus and hCBMNCs and hUCMSCs transplantation. | Biological | Group 2: Conventional plus hCBMNCs and hUCMSCs therapy |
| Conventional therapyParticipants will be given conventional therapy only. | Drug | Group 3:Conventional therapy |
Primary outcome
The ratio of wound contraction and re-epithelialisation
Time frame: 6 months after treatment
Complete healing time for investigated burn area
Time frame: 6 months after treatment
Vancouver Scar Scale
Time frame: 6 months after treatment
4 secondary outcomes
Incidence of infections and bleedings in burn wounds
Time frame: 6 months after treatment]
Engraftment assessment: Vitality of the graft
Time frame: 6 months after treatment]
McGill pain Questionnaire
Time frame: 6 months after treatment
Incidence of Adverse Events and Serious Adverse Events
Time frame: 6 months after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2012.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing human umbilical cord mesenchymal stem cells, human cord blood mononuclear cells and human umbilical cord mesenchymal stem cells and Conventional therapy in people with Burns, run by Shenzhen Beike Bio-Technology Co., Ltd. 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 4 inclusion and 11 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 28 Nov 2012. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Jinfeng Fu (86-871-5351281, ynfjf@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The ratio of wound contraction and re-epithelialisation (time frame: 6 months after treatment). The study lists 3 primary outcomes in all. 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 28 Nov 2012.