Peripheral Arterial DiseasePhase 1/2NCT02287831
Umbilical Cord Mesenchymal Stem Cells Injection for Peripheral Arterial Disease
A Phase 1/2 study testing umbilical cord mesenchymal stem cells in people with Peripheral Arterial Disease, run by Institute of Hematology & Blood Diseases Hospital, China.
Trial summary
The purpose of this study is to assess the safety and efficacy of umbilical cord blood mesenchymal stem cells with peripheral arterial disease. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- umbilical cord mesenchymal stem cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- Feb 2014to 26 Dec 2022
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age of 18-75 years
- Patients confirmed diagnosed peripheral vascular disease , ankle-brachial index < 0.9
- Poor distal arterial outflow tract
- Patient had at least 3 months conservative treatment ,which resulted in little or no improvement
- Poor physical condition can not tolerate surgery
- Patients are willing to participate in the study and sign the informed consent.
Who cannot join
- Renal function damage (over 2 X upper normal range) Liver function damage (over 3 X upper normal range )
- Severe or acute organ damage
- Presence of malignancy
- Pregnancy or lactating patients
- HIV positive
- ABI≧0.9
Show all 15Show fewer
- A history of severe allergies related cell therapy
- Conservative treatment < 3 months
- Acute limb ischemia
- Local obvious infection uncontrolled
- Alcoholics or drug abusers within a year
- Severe psychiatric disorder.
- Patients need surgical treatment
- Above the ankle gangrene
- Patients with other factors which were considered not to be suitable to participate in the study by the investigators.
About this study
Official title: Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cell Injection for Peripheral Arterial Disease
The purpose of this study is to assess the safety and efficacy of umbilical cord blood mesenchymal stem cells with peripheral arterial disease.
Read the detailed description
The present study is designed to implant UCB-MSC in patients with CLI, which are resulted from peripheral arterial disease,such as thromboangiitis obliterans, atherosclerosis obliterans and diabetic foot, and to evaluate the safety and efficacy of the implantation procedure.
- Conditions
- Peripheral Arterial Disease
- Being tested
- umbilical cord mesenchymal stem cells
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
umbilical cord mesenchymal stem cellsBiological
| Study group | Role | What they receive |
|---|---|---|
| umbilical cord mesenchymal stem cells | Experimental | Multiple intra muscular injection of mesenchymal stem cells derived from human umbilical cord. Receives: Biological: umbilical cord mesenchymal stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate safety and tolerability related to the intramuscular injection of autologous Umbilical cord blood derived stem cells.
Amputation rate and mortality will be combined to report safty in %
Measured: 6 months
Secondary outcomes (1)
To evaluate effectiveness related to the intramuscular injection of autologous Umbilical cord blood derived stem cells.
Rest pain, temperature of skin and cold feeling will be combined to report effectiveness in score.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2014 (estimated)
- Study startFeb 2014
- Primary completionDec 2022
- Study completion26 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pingping Huang,MD, Institute of Hematology & Blood Diseases Hospital, China
- Investigators
- Pingping Huang, M.D., Principal investigator, Institute of Hematology & Blood Diseases Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02287831
- Sponsor's protocol ID
- 13ZCZDSY02200
- Status last verified
- Jan 2023
- First submitted
- 2 Nov 2014
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cell Injection for Peripheral Arterial Disease
- ClinicalTrials.gov ID
- NCT02287831
- Acronym / sponsor ID
- 13ZCZDSY02200
- Conditions
- Peripheral Arterial Disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Dec 2022 (actual)
- Study completion
- 26 Dec 2022 (actual)
- First posted
- 11 Nov 2014 (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.
The purpose of this study is to assess the safety and efficacy of umbilical cord blood mesenchymal stem cells with peripheral arterial disease.
Detailed description
The present study is designed to implant UCB-MSC in patients with CLI, which are resulted from peripheral arterial disease,such as thromboangiitis obliterans, atherosclerosis obliterans and diabetic foot, and to evaluate the safety and efficacy of the implantation procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| umbilical cord mesenchymal stem cells | Experimental | Biological: umbilical cord mesenchymal stem cellsMultiple intra muscular injection of mesenchymal stem cells derived from human umbilical cord. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age of 18-75 years
- Patients confirmed diagnosed peripheral vascular disease , ankle-brachial index < 0.9
- Poor distal arterial outflow tract
- Patient had at least 3 months conservative treatment ,which resulted in little or no improvement
- Poor physical condition can not tolerate surgery
Key exclusion criteria (15 listed)
- Renal function damage (over 2 X upper normal range) Liver function damage (over 3 X upper normal range )
- Severe or acute organ damage
- Presence of malignancy
- Pregnancy or lactating patients
- HIV positive
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 |
|---|---|---|
| umbilical cord mesenchymal stem cells | Biological | umbilical cord mesenchymal stem cells |
Primary outcome
To evaluate safety and tolerability related to the intramuscular injection of autologous Umbilical cord blood derived stem cells.
Time frame: 6 months
Amputation rate and mortality will be combined to report safty in %
1 secondary outcome
To evaluate effectiveness related to the intramuscular injection of autologous Umbilical cord blood derived stem cells.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
Related trials for Peripheral Arterial Disease
Active, not recruiting
SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study
Peripheral Artery Disease
RecruitingPhase 3
Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease
Peripheral Artery Disease (PAD)
Recruiting
The THOR IDE Study
Peripheral Artery Disease, Peripheral Artery Stenosis
Not yet recruiting
Daily Stretching to Improve Walking in Older Patients With Peripheral Artery Disease: The STRETCH PAD Study
Peripheral Artery Disease (PAD), Intermittent Claudication
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
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.
Pingping Huang, M.D. principal investigator
Institute of Hematology & Blood Diseases Hospital, China
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing umbilical cord mesenchymal stem cells in people with Peripheral Arterial Disease, run by Institute of Hematology & Blood Diseases Hospital, 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 6 inclusion and 15 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: finished, as of the sponsor's last update on 8 Feb 2023. 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate safety and tolerability related to the intramuscular injection of autologous Umbilical cord blood derived stem cells. (time frame: 6 months). 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 8 Feb 2023.