Stem Cell Transplant ComplicationsPhase 1/2NCT03975101
Very Small Embryonic-like Stem Cells for Knee Osteoarthritis
A Phase 1/2 study testing very small embryonic-like stem cell in people with Stem Cell Transplant Complications and Knee Osteoarthritis, run by Fuda Cancer Hospital, Guangzhou at 1 site in China.
Trial summary
The aim of this study is the safety and efficacy of autologous very small embryonic-like stem cells(VSELs) to knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 50 to 60 years
- Conditions the study is for
- Stem Cell Transplant Complications, Knee Osteoarthritis
- What is being tested?
- very small embryonic-like stem cell
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 5 Jul 2019to 15 Jun 2020
- 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 50 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients had moderate to severe osteoarthritis of both knees.
- Those had mechanical pain of knee joints, which was aggravated by walking or stair climbing.
- Those complained of gelling pain of knee joint.
- Those have crepitus and limitation of the joint range of motion with joint bony hypertrophy on physical examination, X-rays showed narrowing of joint space and osteophyte formation
Who cannot join
- Diabetic foot and patients with obvious edema in the legs caused by various causes
- Blood disease patients, thrombocytopenia or dysfunction, hypofibrinemia or anticoagulant therapy, long-term use of aspirin
Trial locations and contacts
1 site in 1 country.
China1 site
Biological treatment center in Fuda cancer hospital
Guangzhou, Guangdong, 510000
About this study
Official title: Autologous Very Small Embryonic-like Stem Cells(VSELs) for Knee Osteoarthritis
The aim of this study is the safety and efficacy of autologous very small embryonic-like stem cells(VSELs) to knee osteoarthritis.
Read the detailed description
VSELs come from the patient's peripheral blood, and will be injected in the most painful knee, or the worse knee on physical examination. Then follow-up the knee pain and imaging changes at 6 months and 1 year after treatment.
- Being tested
- very small embryonic-like stem cell
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
very small embryonic-like stem cellBiological
Also called VSEL
Mononuclear cells were collected from peripheral blood of each patient using a machine, VSELs were isolated, and each group was injected according to different numbers after activation
| Study group | Role | What they receive |
|---|---|---|
| VSEL Max | Experimental | A mean volume of 5.5 mL platelet-rich plasma containing approximately 120,000 cells were prepared and injected into the selected knee of the patient Receives: Biological: very small embryonic-like stem cell |
| VSEL Medium | Experimental | A mean volume of 5.5 mL platelet-rich plasma containing approximately 90,000 cells were prepared and injected into the selected knee of the patient Receives: Biological: very small embryonic-like stem cell |
| VSEL Mini | Experimental | A mean volume of 5.5 mL platelet-rich plasma containing approximately 60,000 cells were prepared and injected into the selected knee of the patient Receives: Biological: very small embryonic-like stem cell |
| Control | No intervention | A mean volume of 5.5 mL platelet-rich plasma containing no VSELs injected into the selected knee of the patient |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of knee pain score
Pain assessment by visual analogue score (VAS). 0 point: no pain; 1-3 points: there is a slight pain that can be tolerated; 4-6 points: the patient has pain and affects sleep, and can still bear it; 7-10 points: the patient has progressively strong pain, pain is unbearable, affecting appetite and sleep
Measured: 2-4 weeks after injection
Secondary outcomes (4)
Change of knee pain score
Pain assessment by visual analogue score (VAS). 0 point: no pain; 1-3 points: there is a slight pain that can be tolerated; 4-6 points: the patient has pain and affects sleep, and can still bear it; 7-10 points: the patient has progressively strong pain, pain is unbearable, affecting appetite and sleep
Measured: 6 months after injection
Imaging changes in the knee joint
Magnetic resonance image (MRI) examination of the smoothness of the knee joint surface, ligament, soft tissue and meniscus damage
Measured: 6 months after injection
Change of knee pain score
Pain assessment by visual analogue score (VAS). 0 point: no pain; 1-3 points: there is a slight pain that can be tolerated; 4-6 points: the patient has pain and affects sleep, and can still bear it; 7-10 points: the patient has progressively strong pain, pain is unbearable, affecting appetite and sleep
Measured: 12 months after injection
Imaging changes in the knee joint
MRI examination of the smoothness of the knee joint surface, ligament, soft tissue and meniscus damage
Measured: 12 months after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2019
- Study start5 Jul 2019
- Primary completion25 May 2020 (estimated)
- Study completion15 Jun 2020 (estimated)
Why it stopped: Policy changes have contributed to the failure to carry out smoothly
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stem Cell Transplant ComplicationsStudies 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
- Model description
- Three experimental groups were injected with different doses of VSEL, and the control group was injected with platelet-containing serum that dissolved VSEL.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fuda Cancer Hospital, Guangzhou
- Sponsor type
- University, hospital or other
- Collaborators
- Guangzhou Four-Leaf Clover HealthTech Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03975101
- Sponsor's protocol ID
- VSEL-knee
- Status last verified
- May 2020
- First submitted
- 31 May 2019
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Very Small Embryonic-like Stem Cells(VSELs) for Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT03975101
- Acronym / sponsor ID
- VSEL-knee
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Policy changes have contributed to the failure to carry out smoothly
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Fuda Cancer Hospital, GuangzhouUniversity, hospital or other
- Collaborators
- Guangzhou Four-Leaf Clover HealthTech Co., Ltd.
- Study start
- 5 Jul 2019 (actual)
- Primary completion
- 25 May 2020 (estimated)
- Study completion
- 15 Jun 2020 (estimated)
- First posted
- 5 Jun 2019 (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.
The aim of this study is the safety and efficacy of autologous very small embryonic-like stem cells(VSELs) to knee osteoarthritis.
Detailed description
VSELs come from the patient's peripheral blood, and will be injected in the most painful knee, or the worse knee on physical examination. Then follow-up the knee pain and imaging changes at 6 months and 1 year after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
- Model description
- Three experimental groups were injected with different doses of VSEL, and the control group was injected with platelet-containing serum that dissolved VSEL.
| Arm | Type | Receives |
|---|---|---|
| VSEL Max | Experimental | Biological: very small embryonic-like stem cellA mean volume of 5.5 mL platelet-rich plasma containing approximately 120,000 cells were prepared and injected into the selected knee of the patient |
| VSEL Medium | Experimental | Biological: very small embryonic-like stem cellA mean volume of 5.5 mL platelet-rich plasma containing approximately 90,000 cells were prepared and injected into the selected knee of the patient |
| VSEL Mini | Experimental | Biological: very small embryonic-like stem cellA mean volume of 5.5 mL platelet-rich plasma containing approximately 60,000 cells were prepared and injected into the selected knee of the patient |
| Control | No intervention | –A mean volume of 5.5 mL platelet-rich plasma containing no VSELs injected into the selected knee of the patient |
Who may qualify
- Ages
- 50 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients had moderate to severe osteoarthritis of both knees.
- Those had mechanical pain of knee joints, which was aggravated by walking or stair climbing.
- Those complained of gelling pain of knee joint.
- Those have crepitus and limitation of the joint range of motion with joint bony hypertrophy on physical examination, X-rays showed narrowing of joint space and osteophyte formation
Key exclusion criteria (2 listed)
- Diabetic foot and patients with obvious edema in the legs caused by various causes
- Blood disease patients, thrombocytopenia or dysfunction, hypofibrinemia or anticoagulant therapy, long-term use of aspirin
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 |
|---|---|---|
| very small embryonic-like stem cellAlso: VSELMononuclear cells were collected from peripheral blood of each patient using a machine, VSELs were isolated, and each group was injected according to different numbers after activation | Biological | VSEL Max, VSEL Medium, VSEL Mini |
Primary outcome
Change of knee pain score
Time frame: 2-4 weeks after injection
Pain assessment by visual analogue score (VAS). 0 point: no pain; 1-3 points: there is a slight pain that can be tolerated; 4-6 points: the patient has pain and affects sleep, and can still bear it; 7-10 points: the patient has progressively strong pain, pain is unbearable, affecting appetite and sleep
4 secondary outcomes
Change of knee pain score
Time frame: 6 months after injection
Imaging changes in the knee joint
Time frame: 6 months after injection
Change of knee pain score
Time frame: 12 months after injection
Imaging changes in the knee joint
Time frame: 12 months after injection
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Individual participant dataSharing planned: No
Related trials for Stem Cell Transplant Complications
Active, not recruitingPhase 2
MT2013-31: Allo HCT for Metabolic Disorders and Severe Osteopetrosis
Mucopolysaccharidosis Disorders, Hurler Syndrome
Active, not recruitingObservational study
Vaginal Microbiome and the Development of Vulvovaginal Graft Versus Host Disease
Bone Marrow Transplant Complications
Not yet recruitingPhase 1
Expanded Donor Stem Cells for Poor Graft Function After Stem Cell Transplantation in Children
Poor Graft Function, Hematopoietic Stem Cell Transplantation Complications
Active, not recruiting
Impact of Exercise on the Complications of Corticosteroids in Patients With GVHD: the RESTART Trial
Graft Vs Host Disease, Acute-graft-versus-host Disease
Not yet recruitingObservational study
Assessing the Incidence of Transplant Associated Thrombotic Microangiopathy (TA-TMA) in Adult Patients Undergoing Allogeneic Stem Cell Transplant (SCT)
Transplant Associated Microangiopathy TAM, Transplant Complication
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.
The record lists no contact. Use the official record to reach the sponsor.
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 very small embryonic-like stem cell in people with Stem Cell Transplant Complications and Knee Osteoarthritis, run by Fuda Cancer Hospital, Guangzhou 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 2 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: withdrawn, as of the sponsor's last update on 19 Oct 2020. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Change of knee pain score (time frame: 2-4 weeks after injection). 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 19 Oct 2020.