Autologous Adipose Tissue Derived Mesenchymal Stem Cells Therapy for Patients With Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

Official title:

Autologous Adipose Tissue Derived Mesenchymal Stem Cells Therapy for Patients With Knee Osteoarthritis by Intra-articular Injection: A PhaseⅠ/Ⅱa, Randomized and Double-blinded Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01809769
• Other study ID #: CBMG-KOA-1.1
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 11, 2013
• Last updated: April 1, 2016
• Start date: March 2013
• Est. completion date: July 2015

Study information

• Verified date: April 2016
• Source: Cellular Biomedicine Group Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Two injections in total and 3 ml autologous adipose-tissue-derived stem cells(haMSCs) for each injection; time-points for intervention: 1) initial injection; 2) 3 weeks following initial injection.

Description:

Adipose (fat) tissue is removed by lipo-aspiration (this may take up to 40 minutes). The fat is processed on-site to isolate and obtain the MSCs,then proliferate them. The suspension of the cells is injected into the knee joint under ultrasound guidance. (about 20 minutes).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: July 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 70 Years

Eligibility

Inclusion Criteria:

• Subjects who understand and sign the consent form for this study.

• Age: 40-70, males and females.

• Clinical diagnosis of degenerative arthritis by Radiographic Criteria of Kellgren and Lawrence.

• Patients who can't treat with traditional medication and need a arthroplasty.

• Duration of pain over Grade 4(11-point numeric scale)> 4 months.

Exclusion Criteria:

• Women who are pregnant or breast feeding or planning to become pregnant during the study.

• Objects who administer with a anti-inflammatory drugs within 14 days prior to inclusion in the study.

• History or current evidence of alcohol or drug abuse or is a recreational user of illicit drugs or prescription medications.

• Treatment with intra-articular injection therapy within 2 months prior to screen.

• Other joint diseases except degenerative arthritis : systemic or rheumatic or inflammatory chondropathy, chondrocalcinosis, hemachromatosis, inflammatory joint disease, avascular necrosis of the femoral head, Paget's disease, hemophilic arthropathy, infectional arthritis, Charcot's disease, villonodular synovitis, synovial chondromatosis.

• Positive serology for HIV-1 or HIV-2, Hepatitis B (HBsAg, Anti-HCV-Ab), Hepatitis C (Anti-HCV-Ab) and syphilis.

• Serious pre-existing medical conditions like Cardiovascular Diseases, Renal Diseases, Liver Diseases, Endocrine Diseases, Cancer and Diabetes Mellitus.

• Overweight expressed as body mass index (BMI) greater than 30 (obesity grade II).

• Participation in another clinical trial or treatment with a different investigational product within 3 months prior to inclusion in the study.

• Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Biological:
• Mesenchymal stem cells low-dose group
Biological: Adipose tissue derived mesenchymal stem cells administrated for intra-articular use
• Mesenchymal stem cells mid-dose group
Biological: Adipose tissue derived mesenchymal stem cells administrated for intra-articular use
• Mesenchymal stem cells high-dose group
Biological: Adipose tissue derived mesenchymal stem cells administrated for intra-articular use

Locations

Country	Name	City	State
China	Department of Rheumatology,Ren Ji Hospital,School of Medicine,Shanghai Jiao Tong University,Shanghai,China	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Cellular Biomedicine Group Ltd.	RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recording of Adverse Events and Serious Adverse Events		12 weeks	Yes
Primary	Electrocardiogram		9 weeks	Yes
Primary	Vital signs		9 weeks	Yes
Primary	Physical examination		9 weeks	Yes
Primary	WOMAC Score(The Western Ontario and McMaster Universities Osteoarthritis Index)		24 months	No
Primary	Laboratory tests	Routine blood and urine tests, hepatic and renal functions tests, blood lipid and glucose tests, immunologic tests	9 weeks	Yes
Secondary	SF-36		24 months	No
Secondary	NRS-11		24 months	No
Secondary	The volume of articular cartilage		24 months	No