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Clinical Trial of Allogenic Adipose Tissue-Derived Mesenchymal Progenitor Cells Therapy for Knee 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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02641860
Recruitment Status : Completed
First Posted : December 30, 2015
Last Update Posted : September 13, 2018
Sponsor:
Collaborator:
RenJi Hospital
Information provided by (Responsible Party):
Cellular Biomedicine Group Ltd.

Brief Summary:
Evaluate the safety and efficacy of Allogenic Adipose Tissue-Derived Mesenchymal Progenitor Cells Therapy for Knee Osteoarthritis.

Condition or disease Intervention/treatment Phase
Osteoarthritis Biological: Mesenchymal progenitor cells Phase 1

Detailed Description:

A Phase I, Randomized, Single-centered, Double-blinded Clinical Trial of Allogenic Adipose Tissue-Derived Mesenchymal Progenitor Cells Therapy for Knee Osteoarthritis.

This is a randomized,single-blind, double-blinded,phase I clinical trial. Subjects who are with a clinical diagnosis of knee osteoarthritis cartilage defects and will be randomly distributed 1:1:1 to different dosage group after signing the ICF and screening tests.The treatment will accept Allogenic ReJoinTM at the first and fourth week.The duration of the therapy is 48 weeks.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase I, Randomized, Single-centered, Double-blinded Clinical Trial of Allogenic Adipose Tissue-Derived Mesenchymal Progenitor Cells Therapy for Knee Osteoarthritis
Actual Study Start Date : December 2015
Actual Primary Completion Date : March 2018
Actual Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Mesenchymal progenitor cells Dosage 1
Mesenchymal progenitor cells low-dose group
Biological: Mesenchymal progenitor cells
Biological: Allogenic Adipose tissue-derived mesenchymal progentior cells administrated for intra-articular use

Mesenchymal progenitor cells Dosage 2
Mesenchymal progenitor cells mid-dose group
Biological: Mesenchymal progenitor cells
Biological: Allogenic Adipose tissue-derived mesenchymal progentior cells administrated for intra-articular use

Mesenchymal progenitor cells Dosage 3
Mesenchymal progenitor cells high-dose group
Biological: Mesenchymal progenitor cells
Biological: Allogenic Adipose tissue-derived mesenchymal progentior cells administrated for intra-articular use




Primary Outcome Measures :
  1. Safety, recording of Adverse Events and Serious Adverse Events [ Time Frame: 12 weeks,48 weeks ]
  2. WOMAC Score [ Time Frame: 48 weeks ]

Secondary Outcome Measures :
  1. VAS Score [ Time Frame: 48 weeks ]
  2. SF-36 [ Time Frame: 48 Weeks ]
  3. The volume of articular cartilage [ Time Frame: 48 weeks ]
  4. WORMS Score [ Time Frame: 48 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Object has an allergic history or is of an allergic constitution.
  • Subjects who understand and sign the consent form for this study.
  • Age: 18-70, males and females.
  • Clinical diagnosis of degenerative arthritis by Radiographic Criteria of KellgrenLawrence:Duration of pain over Grade 4(11-point numeric scale)> 4 months.
  • Course of Knee osteoarthritis:6 months to 10 years;
  • The VAS score :3-8 points.(the data acquisition time is to stop using all analgesic at least 3 days ).

Exclusion Criteria:

  • The subject has an allergic history of medicine or food。.
  • The subject'BMI is over 30.
  • The subject has uncontrolled or hard-to-control diseases of cardiovascular, liver, kidney or lung, endocrine system.
  • The subject has an history malignant tumour.
  • The subject has complications or diseases of: systemic or rheumatoid arthritis, Chondrocalcinosis articularis, Hemochromatosis,inflammatory arthropathy,avascular necrosis of femoral head,Paget's disease,hemophilic arthropathy,infectional arthritis,Charcot's disease,villonodular synovitis or synovial chondromatosis.
  • The subject has severe generalized infectious diseases or local knee infection in the 3 months prior to this trial.
  • The subject has disease of lower limbs which may be interfered knee evaluation, for example fibromyalgia, osphyalgia, lumbar disc protrusion and so on.
  • The subject has coagulation disorders.
  • The subject has received arthroscopic surgery or intra-articular operations in the 6 months prior to this trial.
  • The subject has received other intra-articular injections for KOA in the 6 months preceding the trial.
  • The subject has received aminoglucose or chondroitin sulfate in the 6 months preceding the trial.
  • The subject has plan of knee prosthesis within the trial.
  • The subject has contraindication of MRI, included but not only: the subject installed heart pacemaker、defibrillator、heart bracket、heart valve prosthesis、metal clip after aneurysm surgery、drug infusion device implanted in vivo、any electronic device implanted in the body(nerve stimulator、bone growth stimulator)、endovascular coil、strainer、ECG monitor、metal suture、shrapnel or sand of body, plate fixation and steel nail after fracture

    - Page 4 of 4 [DRAFT] - surgery、artificial limb or joint、audiphone、artificial cochlea、middle ear shift plant、metallic intraocular foreign body etc; claustrophobia、pregnancy within 3 months、critically ill patients.

  • The subject tests positive for: HIV, hepatitis virus, syphilis or other infectious diseases.
  • The subject has history of alcoholism, drug abuse, or mental illness in the 3 years prior to this trial.
  • The subject has participated in any other clinical trial in the 3 months prior to this trial.
  • The subject is pregnant, lactating or planning to conceive within the next 6 months.
  • The subject has any other unsuitable or adverse condition to be determined by the investigator.

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): NCT02641860


Locations
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China, Shanghai
Department of Rheumatology,Ren Ji Hospital,School of Medicine,Shanghai Jiao Tong University,Shanghai,China
Shanghai, Shanghai, China, 200127
Sponsors and Collaborators
Cellular Biomedicine Group Ltd.
RenJi Hospital

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Responsible Party: Cellular Biomedicine Group Ltd.
ClinicalTrials.gov Identifier: NCT02641860     History of Changes
Other Study ID Numbers: CBMG-Allo-KOA-1.1
First Posted: December 30, 2015    Key Record Dates
Last Update Posted: September 13, 2018
Last Verified: September 2018
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases