Clinical Study of Pulp Mesenchymal Stem Cells in the Treatment of Primary Mild to Moderate Knee Osteoarthritis
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| ClinicalTrials.gov Identifier: NCT04130100 |
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Recruitment Status : Unknown
Verified October 2019 by CAR-T (Shanghai) Biotechnology Co., Ltd..
Recruitment status was: Recruiting
First Posted : October 17, 2019
Last Update Posted : October 17, 2019
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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
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Knee Osteoarthritis | Biological: Low Dose of Mesenchymal stem cell Biological: High Dose of Mesenchymal stem cell Drug: Sodium Hyaluronate | Early Phase 1 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 60 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | low dose of dental pulp mesenchymal stem cells high dose of dental pulp mesenchymal stem cells Sodium hyaluronate |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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. |
| Actual Study Start Date : | April 4, 2019 |
| Estimated Primary Completion Date : | September 30, 2021 |
| Estimated Study Completion Date : | December 30, 2021 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Low Dose of Mesenchymal stem cell
Patients receiving intraarticular injection of low dose of mesenchymal stem cells.
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Biological: Low Dose of Mesenchymal stem cell
Mesenchymal stem cell injection
Other Name: 1 |
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Experimental: High Dose of Mesenchymal stem cell
Patients receiving intraarticular injection of high dose of mesenchymal stem cells.
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Biological: High Dose of Mesenchymal stem cell
Mesenchymal stem cell injection
Other Name: 2 |
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Active Comparator: Sodium Hyaluronate
Patients receiving intraarticular injection of Sodium Hyaluronate
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Drug: Sodium Hyaluronate
Sodium Hyaluronate injection
Other Name: 3 |
- 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
- Volume of femoral surface of knee joint on MRI [ Time Frame: 12 month ]Changes of volume of lateral femoral condylar, medial femoral condylar, lateral tibial condylar, medial tibial condylar and posterior patellar articular surfaces on MRI
- relaxation time of femoral surface of knee joint on MRI [ Time Frame: 12 month ]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
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| Ages Eligible for Study: | 40 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
(1) 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.
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04130100
| Contact: Dongbao Zhao, Doctor | +86-18317079530 | aolin_521@163.com |
| China | |
| Changhai hospital | Recruiting |
| Shanghai, China | |
| Contact: Guangrong Song, Doctor +86-13918384480 songguangrong@cart-sh.com | |
| Principal Investigator: | Dongbao Zhao, Doctor | Changhai Hospital |
| Responsible Party: | CAR-T (Shanghai) Biotechnology Co., Ltd. |
| ClinicalTrials.gov Identifier: | NCT04130100 |
| Other Study ID Numbers: |
KT005SH002 |
| First Posted: | October 17, 2019 Key Record Dates |
| Last Update Posted: | October 17, 2019 |
| Last Verified: | October 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Osteoarthritis Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |
Hyaluronic Acid Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Viscosupplements Protective Agents |