Clinical Trial of Autologous Adipose Tissue-Derived Mesenchymal Progenitor Cells (MPCs) Therapy for Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

Official title:

A PhaseⅡb, Randomized, Double-blinded, Clinical Trial of Autologous Adipose Tissue-Derived Mesenchymal Progenitor Cells Therapy for Knee Osteoarthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02162693
• Other study ID #: CBMG-KOA-?b
• Status: Completed
• Phase: Phase 2
• First received: March 19, 2014
• Last updated: November 14, 2017
• Start date: November 2013
• Est. completion date: November 2016

Study information

• Verified date: November 2017
• Source: Cellular Biomedicine Group Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Current medication treatments for KOA aim to relieve inflammation and pain, but they do little to delay or reverse the disease progression and most medications have obvious side effects. When the conservative treatments are useless to patients and joint deformities and joint disfunction, the patients may require surgery. Although surgery of the joints can relieve the pain temporarily, long-term effect (over 10 years) is hard to achieve.

Description:

Human adipose-derived mesenchymal progenitor cells (haMPCs) are obtained through a series of procedures: firstly, the fresh adipose tissue is digested with collagenase, filtered, centrifuged and then discard mature adipose cells to obtain adipose tissue-derived nuclear cells also called stromal vascular fraction cells (SVFs). In the end, haMPCs are prepared after being purified andamplified to P2-P5. When induced by specific factors, haMPCs have a potential for multilineage differentiation towards bone, cartilage and fat tissue both in vivo and in vitro. The haMPCs can secrete a number of soluble mediators to stimulate the proliferation of endogenous progenitor cells, to act as nutrients, to be immunosuppressive, to be anti-inflammatory, to prevent fibrosis and promote angiogenesis. The cytokines secreted by haMPCs play a synergic role in restoring the dynamic balance of synthesis and decompositon of cartilage tissue, and finally to repair the impaired cartilage.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: November 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. The subject is between 18-70 years of age, regardless of gender

2. The subject has a Kellgren-Lawrence grading, as determined by American College of Rheumatology (ACR) criteria for osteoarthritis of the knee, below grade 4

3. The subject or the subject's legally acceptable representative must be willing to participate in the trial, to receive cell therapy and to provide signed and dated informed consent forms

Exclusion Criteria:

1. The subject has an allergic history or is of an allergic constitution

2. The subject has uncontrolled or hard-to-control diseases of heart, liver, kidney or lung

3. The subject has uncontrolled or hard-to-control diseases of cardiovascular or endocrine system

4. The subject has severe infectious diseases or a malignant tumour

5. The subject has coagulation disorders

6. The subject has a BMI of over 30

7. The subject has used traditional Chinese medicine containing anti-inflammatory agents in the 2 weeks preceding the trial

8. The subject has received other intra-articular injections in the 2 months preceding the trial

9. The subject has complications or diseases of: systemic or rheumatoid arthritis, Chondrocalcinosis articular, Hemochromatosis,inflammatory arthropathy,avascular necrosis of femoral head,Paget's disease,hemophilic arthropathy,infectional arthritis,Charcot's disease,villonodular synovitis or synovial chondromatosis

10. The subject tests positive for: HIV, hepatitis virus, syphilis or other infectious diseases

11. The subject has a history of alcoholism, drug abuse, or mental illness

12. The subject has participated in any other clinical trial in the 3 months prior to this trial

13. The subject is pregnant, lactating or is planning to conceive within the next 6 months

14. The subject has any other unsuitable or adverse condition to be determined by the investigator

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Biological:
• Mesenchymal progenitor cells
Administrated for intra-articular injection
• Sodium Hyaluronate

Locations

Country	Name	City	State
China	General Hospital of Chinese Armed Police Force	Beijing
China	Shanghai Renji Hospital	Shanghai

Sponsors (3)

Lead Sponsor	Collaborator
Cellular Biomedicine Group Ltd.	General Hospital of Chinese Armed Police Force, RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	WOMAC Score(The Western Ontario and McMaster Universities Osteoarthritis Index)		12 months
Secondary	Recording of Adverse Events and Serious Adverse Events		12 months