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Clinical Study of Pulp Mesenchymal Stem Cells in the Treatment of Primary Mild to Moderate Knee Osteoarthritis

Primary Purpose

Knee Osteoarthritis

Status
Unknown status
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
Low Dose of Mesenchymal stem cell
High Dose of Mesenchymal stem cell
Sodium Hyaluronate
Sponsored by
CAR-T (Shanghai) Biotechnology Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Complying with the diagnostic criteria for primary knee osteoarthritis revised by the American Rheumatological Association (1995), age 40-70 years, gender-free.
  2. For patients with mild to moderate knee arthritis, the WOMAC score of knee joint was less than 120.
  3. X-ray Kellgren-Lawrence was used to evaluate the grade I, II and III of osteoarthritis.
  4. 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.
  5. 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.

Sites / Locations

  • Changhai hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Low Dose of Mesenchymal stem cell

High Dose of Mesenchymal stem cell

Sodium Hyaluronate

Arm Description

Patients receiving intraarticular injection of low dose of mesenchymal stem cells.

Patients receiving intraarticular injection of high dose of mesenchymal stem cells.

Patients receiving intraarticular injection of Sodium Hyaluronate

Outcomes

Primary Outcome Measures

Kellgren and Lawrence's rating
X-ray imaging was used to evaluate the degree of improvement in knee joint structure
WOMAC score
WOMAC score decreased

Secondary Outcome Measures

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
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

Full Information

First Posted
October 11, 2019
Last Updated
October 15, 2019
Sponsor
CAR-T (Shanghai) Biotechnology Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04130100
Brief Title
Clinical Study of Pulp Mesenchymal Stem Cells in the Treatment of Primary Mild to Moderate Knee Osteoarthritis
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.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 4, 2019 (Actual)
Primary Completion Date
September 30, 2021 (Anticipated)
Study Completion Date
December 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CAR-T (Shanghai) Biotechnology Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Model Description
low dose of dental pulp mesenchymal stem cells high dose of dental pulp mesenchymal stem cells Sodium hyaluronate
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low Dose of Mesenchymal stem cell
Arm Type
Experimental
Arm Description
Patients receiving intraarticular injection of low dose of mesenchymal stem cells.
Arm Title
High Dose of Mesenchymal stem cell
Arm Type
Experimental
Arm Description
Patients receiving intraarticular injection of high dose of mesenchymal stem cells.
Arm Title
Sodium Hyaluronate
Arm Type
Active Comparator
Arm Description
Patients receiving intraarticular injection of Sodium Hyaluronate
Intervention Type
Biological
Intervention Name(s)
Low Dose of Mesenchymal stem cell
Other Intervention Name(s)
1
Intervention Description
Mesenchymal stem cell injection
Intervention Type
Biological
Intervention Name(s)
High Dose of Mesenchymal stem cell
Other Intervention Name(s)
2
Intervention Description
Mesenchymal stem cell injection
Intervention Type
Drug
Intervention Name(s)
Sodium Hyaluronate
Other Intervention Name(s)
3
Intervention Description
Sodium Hyaluronate injection
Primary Outcome Measure Information:
Title
Kellgren and Lawrence's rating
Description
X-ray imaging was used to evaluate the degree of improvement in knee joint structure
Time Frame
12 month
Title
WOMAC score
Description
WOMAC score decreased
Time Frame
12 month
Secondary Outcome Measure Information:
Title
Volume of femoral surface of knee joint on MRI
Description
Changes of volume of lateral femoral condylar, medial femoral condylar, lateral tibial condylar, medial tibial condylar and posterior patellar articular surfaces on MRI
Time Frame
12 month
Title
relaxation time of femoral surface of knee joint on MRI
Description
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
Time Frame
12 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dongbao Zhao, Doctor
Phone
+86-18317079530
Email
aolin_521@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dongbao Zhao, Doctor
Organizational Affiliation
Changhai Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Changhai hospital
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guangrong Song, Doctor
Phone
+86-13918384480
Email
songguangrong@cart-sh.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Clinical Study of Pulp Mesenchymal Stem Cells in the Treatment of Primary Mild to Moderate Knee Osteoarthritis

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