Umbilical Cord BleedingNCT03358654
Evaluating Safety and Efficacy of Mesenchymal Stem Cells From Umbilical Cord
A study testing mesenchymal stem cells from umbilical cord in people with Umbilical Cord Bleeding and Knee Osteoarthritis, run by Peking University People's Hospital.
Trial summary
This study was to evaluate the safety and efficacy of Mesenchymal Stem Cells (MSCs) from umbilical cord in the treatment of 7 knee OA patients by assessing unexplained local and systemic symptoms or death before and at 1, 2, 3, 6 months after the injection. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Umbilical Cord Bleeding, Knee Osteoarthritis
- What is being tested?
- mesenchymal stem cells from umbilical cord
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2018to 1 Dec 2020
- Phase
- Interventional
- 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
- ① K / L score of 2-3; ② chronic knee pain; ③ no local or systemic infection; ④ without obvious contraindication of the joint puncture from hematology and biochemical tests; ⑤ informed consent. -
Who cannot join
- ① older than 75 years old or less than 18 years old, or without full capacity for civil conduct; ② HIV, hepatitis virus or syphilis virus infection or their serology is positive; ③ BMI index is greater than 30; ④ congenital or acquired knee deformity; ⑤ pregnant or lactating women; ⑥ tumor patients; ⑦ immunodeficiency patients; ⑧ intra-articular drug injection history within 3 months; ⑨ participating in other clinical trials; ⑩ other patients who researchers believe are not eligible for inclusion such as suffering from other concomitant diseases. -
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluating the Safety and Efficacy of Mesenchymal Stem Cells From Umbilical Cord in the Treatment of Knee Joint Osteoarthritis
This study was to evaluate the safety and efficacy of Mesenchymal Stem Cells (MSCs) from umbilical cord in the treatment of 7 knee OA patients by assessing unexplained local and systemic symptoms or death before and at 1, 2, 3, 6 months after the injection.
Read the detailed description
This is a single group assignment study with a total of 9 knee osteoarthritis patients participants. All of the patients will receive the anticular injection with MSCs from umbilical cord and unexplained local and systemic symptoms or death before the end of following-up will be assessed to evaluate the safety and efficacy of mesenchymal stem cells from umbilical cord.
- Conditions
- Umbilical Cord Bleeding, Knee Osteoarthritis
- Being tested
- mesenchymal stem cells from umbilical cord
- Keywords
- Umbilical Cord Bleeding, Knee Osteoarthritis, stem cells
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mesenchymal stem cells from umbilical cordDrug
inject mesenchymal stem cells from umbilical cord，and the patients will be followed up at 1, 2, 3, and 6 months after the injection.
| Study group | Role | What they receive |
|---|---|---|
| mesenchymal stem cells | Experimental | Inject mesenchymal stem cells from umbilical cord. The patients will be followed up at 1, 2, 3, and 6 months after the injection Receives: Drug: mesenchymal stem cells from umbilical cord |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unexplained local and systemic symptoms or death
The severity of AE must be recorded and graded according to the CTCAE criteria, and its relationship to therapy must be assessed according to the following definition:①not related: there is evidence that the cause of adverse events is not due to intra-articular injection therapy (such as previous conditions, potential diseases, concurrent diseases); ②related: AE and intra-articular injection are time-related and it is known or suspected that intra-articular injection of drugs can cause the AE; ③it can't be assessed.
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 posted30 Nov 2017
- Study start1 Jan 2018 (estimated)
- Primary completion1 Jun 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Umbilical Cord BleedingStudies of the same condition, open and under way.
- More trials run by Peking University People's 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yangziyi, Peking University People's Hospital
- Investigators
- Jianhao Lin, MD, Principal investigator, arthritis clinic and research center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03358654
- Sponsor's protocol ID
- PUPH20170911
- Status last verified
- Nov 2017
- First submitted
- 25 Nov 2017
- Last updated
- 30 Nov 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Safety and Efficacy of Mesenchymal Stem Cells From Umbilical Cord in the Treatment of Knee Joint Osteoarthritis
- ClinicalTrials.gov ID
- NCT03358654
- Acronym / sponsor ID
- PUPH20170911
- Conditions
- Umbilical Cord Bleeding, Knee Osteoarthritis
- Keywords
- Umbilical Cord Bleeding, Knee Osteoarthritis, stem cells
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (estimated)
- Primary completion
- 1 Jun 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 30 Nov 2017 (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.
This study was to evaluate the safety and efficacy of Mesenchymal Stem Cells (MSCs) from umbilical cord in the treatment of 7 knee OA patients by assessing unexplained local and systemic symptoms or death before and at 1, 2, 3, 6 months after the injection.
Detailed description
This is a single group assignment study with a total of 9 knee osteoarthritis patients participants. All of the patients will receive the anticular injection with MSCs from umbilical cord and unexplained local and systemic symptoms or death before the end of following-up will be assessed to evaluate the safety and efficacy of mesenchymal stem cells from umbilical cord.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mesenchymal stem cells | Experimental | Drug: mesenchymal stem cells from umbilical cordInject mesenchymal stem cells from umbilical cord. The patients will be followed up at 1, 2, 3, and 6 months after the injection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ① K / L score of 2-3; ② chronic knee pain; ③ no local or systemic infection; ④ without obvious contraindication of the joint puncture from hematology and biochemical tests; ⑤ informed consent. -
Key exclusion criteria (1 listed)
- ① older than 75 years old or less than 18 years old, or without full capacity for civil conduct; ② HIV, hepatitis virus or syphilis virus infection or their serology is positive; ③ BMI index is greater than 30; ④ congenital or acquired knee deformity; ⑤ pregnant or lactating women; ⑥ tumor patients; ⑦ immunodeficiency patients; ⑧ intra-articular drug injection history within 3 months; ⑨ participating in other clinical trials; ⑩ other patients who researchers believe are not eligible for inclusion such as suffering from other concomitant diseases. -
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 |
|---|---|---|
| mesenchymal stem cells from umbilical cordinject mesenchymal stem cells from umbilical cord，and the patients will be followed up at 1, 2, 3, and 6 months after the injection. | Drug | mesenchymal stem cells |
Primary outcome
Unexplained local and systemic symptoms or death
Time frame: 6 months
The severity of AE must be recorded and graded according to the CTCAE criteria, and its relationship to therapy must be assessed according to the following definition:①not related: there is evidence that the cause of adverse events is not due to intra-articular injection therapy (such as previous conditions, potential diseases, concurrent diseases); ②related: AE and intra-articular injection are time-related and it is known or suspected that intra-articular injection of drugs can cause the AE; ③it can't be assessed.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2017.
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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.
Jianhao Lin, MD principal investigator
arthritis clinic and research center
Questions about this trial
What is this clinical trial studying?
A study testing mesenchymal stem cells from umbilical cord in people with Umbilical Cord Bleeding and Knee Osteoarthritis, run by Peking University People's 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 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 30 Nov 2017. 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.
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 Ziyi Yang (+86 18810335110, bjmuyangziyi@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unexplained local and systemic symptoms or death (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 30 Nov 2017.