Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 22 of 55 for:    stem cell arthritis AND stem cell transplantation

Mesenchymal Stem Cell Transplantation for Osteoarthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03969680
Recruitment Status : Recruiting
First Posted : May 31, 2019
Last Update Posted : July 12, 2019
Sponsor:
Information provided by (Responsible Party):
Peiwen Lian, Yantai Yuhuangding Hospital

Brief Summary:
The purpose of this study is to explore the efficacy and safety of autologous bone marrow-derived mesenchymal stem cells (BMSCs) plus autologous platelet rich plasma (PRP) in the treatment of severe knee osteoarthritis.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Biological: Auotologous BMSCs plus autologous PRP Biological: Auotologous PRP Not Applicable

Detailed Description:
This is a single centered, randomized, triple blind phase II clinical study. Patients will be divided into two groups of case and control. Patients of case group will receive intra-articular injection of autologous BMSCs suspended in 3 ml autologous PRP for 3 times, patients of control group will receive intra-articular injection of 3 ml of autologous PRP for 3 times. The investigators designed this clinical study to evaluate therapeutic effects of BM-MSCs in patients with severe knee osteoarthritis.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Autologous Mesenchymal Stem Cell Transplantation for the Treatment of Knee Osteoarthritis
Estimated Study Start Date : July 1, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: BMSCs plus PRP group
Three intra-articular injections in total and autologous bone marrow-derived mesenchymal stem cells (BMSCs) suspended in 3 ml autologous platelet rich plasma (PRP) for each injection. Time-points for intervention: 1) initial injection; 2) 3 months following initial injection; 3) 6 months following initial injection.
Biological: Auotologous BMSCs plus autologous PRP
30 mL of bone marrow will be aspirated from the iliac crests of patients in case group. BMSCs will be isolated from bone marrow and cultured. Before injection, 30 mL of blood will also be collected from each patient to produce 3ml PRP by cenrifugation. Cultured BMSCs will be collected and suspended by 3ml autologous PRP.

Active Comparator: PRP group
Three intra-articular injections in total and 3 ml autologous platelet rich plasma (PRP) for each injection. Time-points for intervention: 1) initial injection; 2) 3 months following initial injection; 3) 6 months following initial injection.
Biological: Auotologous PRP
30 mL of blood will also be collected from each patient to produce 3ml PRP by cenrifugation.




Primary Outcome Measures :
  1. Physical function change [ Time Frame: From before randomization until 3, 6, and 12 months after treatment start. ]
    Evaluation the physical function change Measured by WOMAC osteoarthritis index.

  2. Change in pain density [ Time Frame: From before randomization until 3, 6, and 12 months after treatment start. ]
    Evaluation the changing of pain density measured by Visual Analogue Scale. Draw a 10 cm horizontal line on the paper. One end of the line is 0, indicating no pain; the other end is 10, indicating severe pain; and the middle part indicates varying degrees of pain. The patient selects a point from the horizontal line and the length from 0 to this point is the Visual Analogue Scale score.


Secondary Outcome Measures :
  1. Cartilage repair [ Time Frame: From before randomization until 3, 6, and 12 months after treatment start. ]
    Evaluation of cartilage repair under MRI. Recht criterion was used for grading articular cartilage injury of knee joint, including 0-IV grade, in which: 0 grade, normal articular cartilage, no obvious abnormal signal was found; 1 grade, the layered structure of cartilage disappeared, and there were focal low signal areas, but the surface was smooth; 2 grade, the surface of cartilage was irregular, the depth of cartilage injury was less than 50% cartilage thickness; 3 grade, the surface of cartilage was heavy. The degree of injury is irregular, the depth of injury is more than 50% of the thickness of cartilage or through the whole layer, but the surface of cartilage is not completely exfoliated; Grade IV, full-thickness cartilage defect, articular cartilage injury deep to the cortex, subchondral bone exposed.

  2. Change in MOS item short from health survey(SF-36) [ Time Frame: From before randomization until 3, 6, and 12 months after treatment start. ]
    Evaluation of the health-related quality of life change Measured by MOS item short from health survey(SF-36) after each cell injection. SF-36 is a self-administered questionnaire comprising 36-items measuring eight dimensions of general HRQOL: physical functioning (10 items), role limitation due to physical health problems (4 items), bodily pain (2 items), general health perceptions (5 items), vitality (4 items), social functioning (2 items), role limitations due to emotional problems (3 items), and general mental health (5 items).These outcomes will be grouped as physical component summary and mental component summary. The norm data is 0-100, the health related quality of life is increases as the scores are increased. The average score is 50.

  3. Change in Lequesne Index [ Time Frame: From before randomization until 3, 6, and 12 months after treatment start. ]
    Evaluation of severity of knee symptoms Lequesne Index includes the measurement of pain (5 items), walking distance (2 items), and activities of daily living (4 items). Maximal score is 24 and higher scores represent worse function

  4. Change in knee society score (KSS) [ Time Frame: From before randomization until 3, 6, and 12 months after treatment start. ]
    The knee society score is divided into four parts: it consists of the ''Symptoms''(25 points), the ''Patient satisfaction''(40 points), the ''Patient expectation''(15 points) and the ''Functional activities''(100 points). Each part will be evaluated separately.Higher scores indicate better knee score/satisfaction/functioning or higher expectations.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject has Kellgren and Lawrence grade II-IV primary osteoarthritis as determined by X-ray.
  2. Subject's pain score is 8-13 points (Lequesne's index).
  3. Ages between 40-70 years.
  4. Signed informed consent from the subject.-

Exclusion Criteria:

  1. Subject infected with hepatitis B, hepatitis C, HIV, syphilis or HTLV
  2. Subject not suitable for liposuction surgery.
  3. Subject with hypersensitivity/allergy to anesthetic.
  4. Subject's creatinine values higher than 1.6mg/dl.
  5. Subject with body mass index, BMI over 30.
  6. Subject's studied knee treated with intra-articular injection therapy within 6 months prior to screen.
  7. Subject has undergone surgery on studied knee, including fracture surgery, arthroscopic surgery, meniscus repair surgery, or cruciate ligament reconstruction surgery.
  8. Subject enrolled in any other cell therapy studies within the past 30 days.
  9. Subject who the investigator considers inappropriate for the clinical trial due to any other reasons than those listed above.
  10. Subject has a history of gouty arthritis, septic arthritis, rheumatoid arthritis and any other autoimmune arthritis of the knee joint.
  11. Subject has had major medical problems in vital organs, such as; heart, liver, kidney, or lung.-

Information from the National Library of Medicine

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): NCT03969680


Contacts
Layout table for location contacts
Contact: Jian Chen, PhD +0086 5356691999 ext 81511 chenjianyt@163.com
Contact: Peiwen Lian, PhD +0086 5356691999 ext 82708 peiwen.lian@hotmail.com

Locations
Layout table for location information
China, Shandong
Yantai Yuhuangding Hospital Recruiting
Yantai, Shandong, China, 264000
Contact: Peiwen Lian, PhD    +0086 5356691999 ext 82708    peiwen.lian@qq.com   
Sponsors and Collaborators
Yantai Yuhuangding Hospital
Investigators
Layout table for investigator information
Study Director: Jian Chen, PhD Yantai Yuhuangding Hospital

Layout table for additonal information
Responsible Party: Peiwen Lian, Principle Investigator, Yantai Yuhuangding Hospital
ClinicalTrials.gov Identifier: NCT03969680     History of Changes
Other Study ID Numbers: 2019-002
First Posted: May 31, 2019    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: July 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases