Cartilage DiseasesPhase 1NCT02291926
Human Umbilical Cord Mesenchymal Stem Cell Transplantation in Articular Cartilage Defect
A Phase 1 study testing Human umbilical cord mesenchymal stem cells in people with Cartilage Diseases and Osteoarthritis, run by Shenzhen Hornetcorn Bio-technology Company, LTD at 1 site in China.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of human umbilical cord mesenchymal stem cell(hUC-MSC) for articular cartilage defect of knee. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cartilage Diseases, Osteoarthritis
- What is being tested?
- Human 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
- 20 participants
- Where
- 1 siteChina
- Study dates
- Dec 2014to Dec 2016
- 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
- Patients must consent in writing to participate in the study by signing and dating an informed consent document
- Healthy patients with no major history of illness
- Patients must have a diagnosis of osteoarthritis by radiographic criteria of Kellgren and Lawrence grade 2-4
- Patients who needs invasive interventions of arthroplasty due to no response from existing pain medication
- Patients must have had more than Grade 4 (0~10 point numeric scale) pain at least for four months
- Patient's damaged cartilage area should be in the range of 2-6cm2
Who cannot join
- Pregnant women or lactating mothers
- Patients who have received any anti-inflammatory drugs including herb-drug within 14 days
- Patients who received any drug by intra-articular injection for treatment within 2 months prior to this enrollment
- Patients with positive human immunodeficiency (HIV) at screening indicative of current of pass infection
- Impaired liver function, abnormal blood coagulation, combine other tumor or special condition
- Patients who had participated in other clinical trials within three months prior to this study
Trial locations and contacts
1 site in 1 country.
China1 site
The Fifth Affiliated Hospital Immunotherapy center
Guangzhou, Guangdong, 510000
About this study
Official title: Phase I Study of Human Umbilical Cord Mesenchymal Stem Cell Implantation in the Treatment of Articular Cartilage Defect of Knee
The purpose of this study is to evaluate the safety and efficacy of human umbilical cord mesenchymal stem cell(hUC-MSC) for articular cartilage defect of knee.
Read the detailed description
Human articular cartilage has limited repair potential.Cell-based strategies have explored chondrocytes and mesenchymal stem cells (MSCs) with extensive basic science and preclinical studies.However the concept of autologous chondrocyte implantation is not ideal,so the focus in cartilage repair is shifting toward mesenchymal stem cells.
To investigate the effects of hUC-MSC treatment for articular cartilage defects, 20 patients will be enrolled and receive 4 times of hUC-MSC transplantation.
- Conditions
- Cartilage Diseases, Osteoarthritis
- Being tested
- Human umbilical cord mesenchymal stem cells
- Keywords
- Human Umbilical Cord Mesenchymal Stem Cell, Mesenchymal Stem Cell, Osteoarthritis
- Medical subject headings
- Cartilage Diseases, Osteoarthritis
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
Also called hUC-MSC
A single dose of 2×107 hUC-MSC will be implanted to patients by intra-articular injection, and repeated every month for four times.
| Study group | Role | What they receive |
|---|---|---|
| hUC-MSC treatment | Experimental | Patients will receive human umbilical cord mesenchymal stem cells transplantation with a 12 months follow-up. Receives: Biological: Human umbilical cord mesenchymal stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of adverse events
Adverse events were categorized using National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.0 scale (NCI-CTCAE v4.0).
Measured: 12 months
Secondary outcomes (2)
Magnetic resonance imaging (MRI) of the knee
The size, depth of cartilage defect, and regenerated cartilage were measured using MRI.
Measured: Before and 1,3,6,12 month after treatment
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Change in WOMAC pain score,composite score and function and stiffness index scores.
Measured: Before and 1,3,6,12 month after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2014 (estimated)
- Study startDec 2014
- Primary completionJul 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cartilage DiseasesStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shenzhen Hornetcorn Bio-technology Company, LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fifth Affiliated Hospital of Guangzhou Medical University
- Responsible party
- Sponsor
- Investigators
- Ping J Chen, Professor, Principal investigator, Fifth Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02291926
- Sponsor's protocol ID
- HYK-Articular Cartilage Defect
- Status last verified
- Jul 2015
- First submitted
- 7 Nov 2014
- Last updated
- 10 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Human Umbilical Cord Mesenchymal Stem Cell Implantation in the Treatment of Articular Cartilage Defect of Knee
- ClinicalTrials.gov ID
- NCT02291926
- Acronym / sponsor ID
- HYK-Articular Cartilage Defect
- Conditions
- Cartilage Diseases, Osteoarthritis
- Keywords
- Human Umbilical Cord Mesenchymal Stem Cell, Mesenchymal Stem Cell, Osteoarthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Shenzhen Hornetcorn Bio-technology Company, LTDIndustry (pharma, biotech, devices)
- Collaborators
- Fifth Affiliated Hospital of Guangzhou Medical University
- Study start
- Dec 2014
- Primary completion
- Jul 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 17 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 evaluate the safety and efficacy of human umbilical cord mesenchymal stem cell(hUC-MSC) for articular cartilage defect of knee.
Detailed description
Human articular cartilage has limited repair potential.Cell-based strategies have explored chondrocytes and mesenchymal stem cells (MSCs) with extensive basic science and preclinical studies.However the concept of autologous chondrocyte implantation is not ideal,so the focus in cartilage repair is shifting toward mesenchymal stem cells.
To investigate the effects of hUC-MSC treatment for articular cartilage defects, 20 patients will be enrolled and receive 4 times of hUC-MSC transplantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hUC-MSC treatment | Experimental | Biological: Human umbilical cord mesenchymal stem cellsPatients will receive human umbilical cord mesenchymal stem cells transplantation with a 12 months follow-up. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients must consent in writing to participate in the study by signing and dating an informed consent document
- Healthy patients with no major history of illness
- Patients must have a diagnosis of osteoarthritis by radiographic criteria of Kellgren and Lawrence grade 2-4
- Patients who needs invasive interventions of arthroplasty due to no response from existing pain medication
- Patients must have had more than Grade 4 (0~10 point numeric scale) pain at least for four months
Key exclusion criteria (6 listed)
- Pregnant women or lactating mothers
- Patients who have received any anti-inflammatory drugs including herb-drug within 14 days
- Patients who received any drug by intra-articular injection for treatment within 2 months prior to this enrollment
- Patients with positive human immunodeficiency (HIV) at screening indicative of current of pass infection
- Impaired liver function, abnormal blood coagulation, combine other tumor or special condition
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 cellsAlso: hUC-MSCA single dose of 2×107 hUC-MSC will be implanted to patients by intra-articular injection, and repeated every month for four times. | Biological | hUC-MSC treatment |
Primary outcome
Severity of adverse events
Time frame: 12 months
Adverse events were categorized using National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.0 scale (NCI-CTCAE v4.0).
2 secondary outcomes
Magnetic resonance imaging (MRI) of the knee
Time frame: Before and 1,3,6,12 month after treatment
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: Before and 1,3,6,12 month after treatment
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 10 May 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Cartilage Diseases
Recruiting
BioPoly® Partial Resurfacing Knee Implant IDE
Knee Pain Chronic, Knee Osteoarthritis
RecruitingPhase 3
Phase 3 Pivotal Trial Comparing CARTISTEM® and Surgical Comparator for Knee Cartilage Lesions and Osteoarthritis
Knee Cartilage Defects
RecruitingPhase 3
A Study of MACI in Patients Aged 17 to 65 Years With Symptomatic Chondral or Osteochondral Defects of the Ankle
Chondral Defect, Articular Cartilage Defect
RecruitingPhase 3
A Study of MACI in Patients Aged 10 to 17 Years With Symptomatic Chondral or Osteochondral Defects of the Knee
Chondral Defect, Osteochondritis Dissecans (OCD)
RecruitingObservational study
Studies of the Natural History, Pathogenesis, and Outcome of Idiopathic Systemic Vasculitis
Takayasu's Arteritis, Giant Cell Arteritis
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.
Ping J Chen, Professor principal investigator
Fifth Affiliated Hospital of Guangzhou Medical University
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 Human umbilical cord mesenchymal stem cells in people with Cartilage Diseases and Osteoarthritis, run by Shenzhen Hornetcorn Bio-technology Company, 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 6 inclusion and 6 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 10 May 2017. 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?
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?
Severity of adverse events (time frame: 12 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 10 May 2017.