Knee OsteoarthritisEarly Phase 1NCT04130100
Clinical Study of Pulp Mesenchymal Stem Cells in the Treatment of Primary Mild to Moderate Knee Osteoarthritis
A Early Phase 1 study testing Low Dose of Mesenchymal stem cell, High Dose of Mesenchymal stem cell and Sodium Hyaluronate in people with Knee Osteoarthritis, run by CAR-T (Shanghai) Biotechnology Co., Ltd. at 1 site in China.
Trial summary
To evaluate the clinical efficacy and safety of dental pulp mesenchymal stem cells in the treatment of primary mild to moderate knee osteoarthritis through a comparative study with sodium hyaluronate. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Low Dose of Mesenchymal stem cell, High Dose of Mesenchymal stem cell and Sodium Hyaluronate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 4 Apr 2019to 30 Dec 2021
- Phase
- Early 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Complying with the diagnostic criteria for primary knee osteoarthritis revised by the American Rheumatological Association (1995), age 40-70 years, gender-free.
- For patients with mild to moderate knee arthritis, the WOMAC score of knee joint was less than 120.
- X-ray Kellgren-Lawrence was used to evaluate the grade I, II and III of osteoarthritis.
- Fertility patients should take effective contraceptive measures until the end of follow-up. Fertility women should exclude the possibility of early pregnancy, that is, HCG negative test in early pregnancy.
- Voluntary participation in this clinical study, can cooperate with doctors to carry out research, stop all medical measures for knee arthritis for more than 2 weeks, and sign the informed consent of patients.
Who cannot join
- Those with other diseases that may affect the knee joint, such as rheumatoid arthritis, ankylosing spondylitis, rheumatoid arthritis, gout and other rheumatic diseases, bone tumors, osteoporosis, bone tuberculosis or obvious history of acute trauma, resulting in meniscus injury, ligament rupture and vascular nerve injury; those with previous history of femur, tibial plateau, tibia and fibula fracture. The patients with gonarthritis, the patients with knee joint and surrounding skin infection were not cured.
- 2) Patients who have undergone surgery and other factors affecting the efficacy of the treatment. Patients with severe deformities or even deformities of the knee joint, who need surgical treatment. Patients who have received knee joint irrigation or arthroscopic examination within one year.
- 3) Patients with systemic cancer tendency or cancer and patients with systemic infection in active stage.
- 4) Patients with severe heart, lung, liver, kidney, blood system, endocrine system and immune deficiency, or abnormal laboratory biochemical indicators, namely: hemoglobin (Hb) < 9 g/dL, white blood cell (WBC) > 15 x 109/L, platelet (Pt) < 100 x 109/L, glutamic oxalate transaminase (AST) and alanine aminotransferase (ALT) > 1.5 times normal upper limit; serum creatinine > 1.5 times normal upper limit.
- 5) Physical history or clinical manifestations with bleeding tendency, including patients currently using anticoagulants.
- 6) Patients with uncontrollable epileptic seizures, psychosis or Alzheimer's disease who are unable to complete the scale.
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- 7) Pregnant or lactating women, legal disabled patients (blind, deaf, dumb, mentally retarded, physically disabled), drug addiction and other adverse drug addiction.
- 8) Patients with contraindications or allergies were examined and treated in this study.
- 9) Those who have participated in other clinical studies within one month.
- 10) Researchers consider it inappropriate for patients to participate in this clinical study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Changhai hospital
Shanghai
Guangrong Song, Doctor, +86-13918384480, songguangrong@cart-sh.com
About this study
Official title: To Evaluate the Safety and Efficacy of Dental Pulp Mesenchymal Stem Cells in the Treatment of Primary Mild to Moderate Knee Osteoarthritis Using Sodium Hyaluronate as a Parallel Control.
To evaluate the clinical efficacy and safety of dental pulp mesenchymal stem cells in the treatment of primary mild to moderate knee osteoarthritis through a comparative study with sodium hyaluronate.
20 participants will receive low dose of dental pulp mesenchymal stem cells, 20 participants will receive high dose and another 20 participants will receive sodium hyaluronate
Read the detailed description
60 participants will receive to evaluate the clinical efficacy and safety of dental pulp mesenchymal stem cells in the treatment of primary mild to moderate knee osteoarthritis through a comparative study with sodium hyaluronate and verify the basis of dental pulp mesenchymal stem cells in the treatment of primary knee osteoarthritis, and to explore a more effective and safe clinical treatment of knee osteoarthritis.
- Conditions
- Knee Osteoarthritis
- Being tested
- Low Dose of Mesenchymal stem cell, High Dose of Mesenchymal stem cell, Sodium Hyaluronate
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Dose of Mesenchymal stem cellBiological
Also called 1
Mesenchymal stem cell injection
High Dose of Mesenchymal stem cellBiological
Also called 2
Mesenchymal stem cell injection
Sodium HyaluronateDrug
Also called 3
Sodium Hyaluronate injection
| Study group | Role | What they receive |
|---|---|---|
| Low Dose of Mesenchymal stem cell | Experimental | Patients receiving intraarticular injection of low dose of mesenchymal stem cells. Receives: Biological: Low Dose of Mesenchymal stem cell |
| High Dose of Mesenchymal stem cell | Experimental | Patients receiving intraarticular injection of high dose of mesenchymal stem cells. Receives: Biological: High Dose of Mesenchymal stem cell |
| Sodium Hyaluronate | Active comparator | Patients receiving intraarticular injection of Sodium Hyaluronate Receives: Drug: Sodium Hyaluronate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kellgren and Lawrence's rating
X-ray imaging was used to evaluate the degree of improvement in knee joint structure
Measured: 12 month
WOMAC score
WOMAC score decreased
Measured: 12 month
Secondary outcomes (2)
Volume of femoral surface of knee joint on MRI
Changes of volume of lateral femoral condylar, medial femoral condylar, lateral tibial condylar, medial tibial condylar and posterior patellar articular surfaces on MRI
Measured: 12 month
relaxation time of femoral surface of knee joint on MRI
Changes of relaxation time (T1 condylar, T2 condylar, T2*) of lateral femoral condylar, medial femoral condylar, lateral tibial condylar, medial tibial condylar and posterior patellar articular surfaces on MRI
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2019
- Study start4 Apr 2019
- Primary completion30 Sep 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- low dose of dental pulp mesenchymal stem cells high dose of dental pulp mesenchymal stem cells Sodium hyaluronate
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CAR-T (Shanghai) Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dongbao Zhao, Doctor, Principal investigator, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04130100
- Sponsor's protocol ID
- KT005SH002
- Status last verified
- Oct 2019
- First submitted
- 11 Oct 2019
- Last updated
- 17 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- 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 17 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Safety and Efficacy of Dental Pulp Mesenchymal Stem Cells in the Treatment of Primary Mild to Moderate Knee Osteoarthritis Using Sodium Hyaluronate as a Parallel Control.
- ClinicalTrials.gov ID
- NCT04130100
- Acronym / sponsor ID
- KT005SH002
- Conditions
- Knee Osteoarthritis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- CAR-T (Shanghai) Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Apr 2019 (actual)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 17 Oct 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.
To evaluate the clinical efficacy and safety of dental pulp mesenchymal stem cells in the treatment of primary mild to moderate knee osteoarthritis through a comparative study with sodium hyaluronate.
20 participants will receive low dose of dental pulp mesenchymal stem cells, 20 participants will receive high dose and another 20 participants will receive sodium hyaluronate
Detailed description
60 participants will receive to evaluate the clinical efficacy and safety of dental pulp mesenchymal stem cells in the treatment of primary mild to moderate knee osteoarthritis through a comparative study with sodium hyaluronate and verify the basis of dental pulp mesenchymal stem cells in the treatment of primary knee osteoarthritis, and to explore a more effective and safe clinical treatment of knee osteoarthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- low dose of dental pulp mesenchymal stem cells high dose of dental pulp mesenchymal stem cells Sodium hyaluronate
| Arm | Type | Receives |
|---|---|---|
| Low Dose of Mesenchymal stem cell | Experimental | Biological: Low Dose of Mesenchymal stem cellPatients receiving intraarticular injection of low dose of mesenchymal stem cells. |
| High Dose of Mesenchymal stem cell | Experimental | Biological: High Dose of Mesenchymal stem cellPatients receiving intraarticular injection of high dose of mesenchymal stem cells. |
| Sodium Hyaluronate | Active comparator | Drug: Sodium HyaluronatePatients receiving intraarticular injection of Sodium Hyaluronate |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Complying with the diagnostic criteria for primary knee osteoarthritis revised by the American Rheumatological Association (1995), age 40-70 years, gender-free.
- For patients with mild to moderate knee arthritis, the WOMAC score of knee joint was less than 120.
- X-ray Kellgren-Lawrence was used to evaluate the grade I, II and III of osteoarthritis.
- Fertility patients should take effective contraceptive measures until the end of follow-up. Fertility women should exclude the possibility of early pregnancy, that is, HCG negative test in early pregnancy.
- Voluntary participation in this clinical study, can cooperate with doctors to carry out research, stop all medical measures for knee arthritis for more than 2 weeks, and sign the informed consent of patients.
Key exclusion criteria (10 listed)
- Those with other diseases that may affect the knee joint, such as rheumatoid arthritis, ankylosing spondylitis, rheumatoid arthritis, gout and other rheumatic diseases, bone tumors, osteoporosis, bone tuberculosis or obvious history of acute trauma, resulting in meniscus injury, ligament rupture and vascular nerve injury; those with previous history of femur, tibial plateau, tibia and fibula fracture. The patients with gonarthritis, the patients with knee joint and surrounding skin infection were not cured.
- 2) Patients who have undergone surgery and other factors affecting the efficacy of the treatment. Patients with severe deformities or even deformities of the knee joint, who need surgical treatment. Patients who have received knee joint irrigation or arthroscopic examination within one year.
- 3) Patients with systemic cancer tendency or cancer and patients with systemic infection in active stage.
- 4) Patients with severe heart, lung, liver, kidney, blood system, endocrine system and immune deficiency, or abnormal laboratory biochemical indicators, namely: hemoglobin (Hb) < 9 g/dL, white blood cell (WBC) > 15 x 109/L, platelet (Pt) < 100 x 109/L, glutamic oxalate transaminase (AST) and alanine aminotransferase (ALT) > 1.5 times normal upper limit; serum creatinine > 1.5 times normal upper limit.
- 5) Physical history or clinical manifestations with bleeding tendency, including patients currently using anticoagulants.
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 |
|---|---|---|
| Low Dose of Mesenchymal stem cellAlso: 1Mesenchymal stem cell injection | Biological | Low Dose of Mesenchymal stem cell |
| High Dose of Mesenchymal stem cellAlso: 2Mesenchymal stem cell injection | Biological | High Dose of Mesenchymal stem cell |
| Sodium HyaluronateAlso: 3Sodium Hyaluronate injection | Drug | Sodium Hyaluronate |
Primary outcome
Kellgren and Lawrence's rating
Time frame: 12 month
X-ray imaging was used to evaluate the degree of improvement in knee joint structure
WOMAC score
Time frame: 12 month
WOMAC score decreased
2 secondary outcomes
Volume of femoral surface of knee joint on MRI
Time frame: 12 month
relaxation time of femoral surface of knee joint on MRI
Time frame: 12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2019.
- Individual participant dataSharing planned: No
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The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
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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.
Dongbao Zhao, Doctor principal investigator
Changhai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Low Dose of Mesenchymal stem cell, High Dose of Mesenchymal stem cell and Sodium Hyaluronate in people with Knee Osteoarthritis, run by CAR-T (Shanghai) Biotechnology Co., 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 5 inclusion and 10 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 17 Oct 2019. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Dongbao Zhao, Doctor (+86-18317079530, aolin_521@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kellgren and Lawrence's rating (time frame: 12 month). 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 17 Oct 2019.