Cartilage DamagePhase 1/2NCT02776943
UCMSC Transplantation in the Treatment of Cartilage Damage
A Phase 1/2 study testing umbilical cord mesenchymal stem cells and Hyaluronic acid in people with Cartilage Damage and Degenerative Osteoarthritis, run by South China Research Center for Stem Cell and Regenerative Medicine.
Trial summary
The purpose of this study is to investigate the efficacy and safety of transplantation of umbilical cord mesenchymal stem cells（UCMSCs） in patient with Knee cartilage damage. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cartilage Damage, Degenerative Osteoarthritis
- What is being tested?
- umbilical cord mesenchymal stem cells and Hyaluronic acid
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Jun 2019
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients whose lesion (single joint) should be in the range of 2 cm^2-8 cm^2.
- Patients with pain in affected joint of 60 mm- 100 mm VAS (visual analogue scale)
- Patients with articular swelling, tenderness and active range of motion of Grade 2 or below
- Patients with knee joint cartilage defect or injury of ICRS (International Cartilage Repair Society) Grade 4 confirmed by arthroscopy (At screening, patients diagnosed as such with an MRI may be included)
- Patients who needs invasive interventions of arthroplasty due to no response from existing pain medication
- Patients voluntarily agreed to participate in the study and signed informed consent
Who cannot join
- Patients with autoimmune diseases or medical history
- Patients with infections requiring injection of antibiotics
- Patients with severe internal diseases
- Patients who are currently pregnant or lactation
- Patients who had participated in any other clinical trials within the past four weeks
- Patients who had been administered with immunosuppressants within the past four weeks
- Patients whom the principal investigator considers inappropriate for the clinical trial due to any other reasons than those listed above
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Phase I/II Study of Umbilical Cord Mesenchymal Stem Cell Implantation in the Treatment of Articular Cartilage Defect of Knee and Knee Osteoarthritis
The purpose of this study is to investigate the efficacy and safety of transplantation of umbilical cord mesenchymal stem cells（UCMSCs） in patient with Knee cartilage damage.
Read the detailed description
Human cartilage only has limited regenerative potential. Transplantation of umbilical cord mesenchymal stem cells (UCMSCs) is a promising strategy given the high proliferative capacity of MSCs and their potential to differentiate into cartilage-producing cells - chondrocytes. The acquisition of ucMSCs does not require invasive surgical intervention or cartilage extraction from other sites as required by other cell-based strategies. The investigators inject allogeneic human mesenchymal stem cells to the cartilage lesions in patients via intra-articular injection method, and to investigate the efficacy and safety。
- Conditions
- Cartilage Damage, Degenerative Osteoarthritis
- Being tested
- umbilical cord mesenchymal stem cells, Hyaluronic acid
- Medical subject headings
- Joint Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
umbilical cord mesenchymal stem cellsBiological
Also called UCMSC
Hyaluronic acidDevice
| Study group | Role | What they receive |
|---|---|---|
| Mesenchymal stem cell treatment | Experimental | Umbilical Cord Mesenchymal stem cells (UCMSC) expanded and treated for 1-2 weeks. Then administer 5x10^6 of UCMSC per cm^2 of the cartilage defect. Receives: Biological: umbilical cord mesenchymal stem cells |
| Hyaluronic acid treatment | Active comparator | Administer hyaluronic acid (30 mg) in a single injection Receives: Device: Hyaluronic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Function Change and Improvement
Knee assessments will be performed using the following tools:
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Measured: 12 months after treatment
Knee Function Change and Improvement
Changes in knee function will be assessed via the IKDC score.
Measured: 12 months after treatment
Secondary outcomes (1)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2016 (estimated)
- Study startJun 2016
- Primary completionDec 2018 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cartilage DamageStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South China Research Center for Stem Cell and Regenerative Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02776943
- Sponsor's protocol ID
- UCMSC-4
- Status last verified
- Jan 2016
- First submitted
- 14 Mar 2016
- Last updated
- 18 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study of Umbilical Cord Mesenchymal Stem Cell Implantation in the Treatment of Articular Cartilage Defect of Knee and Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT02776943
- Acronym / sponsor ID
- UCMSC-4
- Conditions
- Cartilage Damage, Degenerative Osteoarthritis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- South China Research Center for Stem Cell and Regenerative MedicineUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 18 May 2016 (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 investigate the efficacy and safety of transplantation of umbilical cord mesenchymal stem cells（UCMSCs） in patient with Knee cartilage damage.
Detailed description
Human cartilage only has limited regenerative potential. Transplantation of umbilical cord mesenchymal stem cells (UCMSCs) is a promising strategy given the high proliferative capacity of MSCs and their potential to differentiate into cartilage-producing cells - chondrocytes. The acquisition of ucMSCs does not require invasive surgical intervention or cartilage extraction from other sites as required by other cell-based strategies. The investigators inject allogeneic human mesenchymal stem cells to the cartilage lesions in patients via intra-articular injection method, and to investigate the efficacy and safety。
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mesenchymal stem cell treatment | Experimental | Biological: umbilical cord mesenchymal stem cellsUmbilical Cord Mesenchymal stem cells (UCMSC) expanded and treated for 1-2 weeks. Then administer 5x10^6 of UCMSC per cm^2 of the cartilage defect. |
| Hyaluronic acid treatment | Active comparator | Device: Hyaluronic acidAdminister hyaluronic acid (30 mg) in a single injection |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients whose lesion (single joint) should be in the range of 2 cm^2-8 cm^2.
- Patients with pain in affected joint of 60 mm- 100 mm VAS (visual analogue scale)
- Patients with articular swelling, tenderness and active range of motion of Grade 2 or below
- Patients with knee joint cartilage defect or injury of ICRS (International Cartilage Repair Society) Grade 4 confirmed by arthroscopy (At screening, patients diagnosed as such with an MRI may be included)
- Patients who needs invasive interventions of arthroplasty due to no response from existing pain medication
Key exclusion criteria (7 listed)
- Patients with autoimmune diseases or medical history
- Patients with infections requiring injection of antibiotics
- Patients with severe internal diseases
- Patients who are currently pregnant or lactation
- Patients who had participated in any other clinical trials within the past four weeks
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 cellsAlso: UCMSC | Biological | Mesenchymal stem cell treatment |
| Hyaluronic acid | Device | Hyaluronic acid treatment |
Primary outcome
Knee Function Change and Improvement
Time frame: 12 months after treatment
Knee assessments will be performed using the following tools: Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Knee Function Change and Improvement
Time frame: 12 months after treatment
Changes in knee function will be assessed via the IKDC score.
1 secondary outcome
Severity of adverse events
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2016.
- Individual participant dataSharing planned: No
Related trials for Cartilage Damage
Recruiting
BioPoly® Partial Resurfacing Knee Implant IDE
Knee Pain Chronic, Knee Osteoarthritis
RecruitingPhase 1
AMIC Compared With Microfracture for Focal Articular Cartilage Damage of the Hip
Hip Arthroscopy, Articular Cartilage Defect
Active, not recruiting
Long-Term Study of CartiPRO for Knee Pain Due to Osteoarthritis or Cartilage Damage
Osteoarthritis, Knee Pain Arthritis
Recruiting
This is a Study to Evaluate Nanofractures Technique in the Treatment of Cartilage Lesions
Cartilage Damage
RecruitingPhase 4
Pilot Exploration of Platelet Characterization of Platelet Rich Plasma Created by Two Different Systems
Knee Osteoarthristis, Cartilage Damage
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.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing umbilical cord mesenchymal stem cells and Hyaluronic acid in people with Cartilage Damage and Degenerative Osteoarthritis, run by South China Research Center for Stem Cell and Regenerative Medicine.
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 7 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 18 May 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xuetao Pei, M.D.,Ph.D (8610-68164807, AMMS0906@163.COM), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee Function Change and Improvement (time frame: 12 months after treatment). The study lists 2 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 18 May 2016.