Allogeneic Mesenchymal Stem Cells in Osteoarthritis

NCT ID: NCT01453738

Last Updated: 2016-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2014-11-30

Brief Summary

This trial is planed to study if allogeneic mesenchymal stem cells would be safe and beneficial in osteoarthritis of knee joint. This is a double blind study. Different doses of stem cells will be used in this study.

Conditions

Osteoarthritis of Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Ex- vivo cultured adult allogeneic MSCs

Single intraarticular dose of allogeneic MSCs suspended in 2-4ml Plasmalyte A followed by 2 ml of Hyaluronan

Group Type: EXPERIMENTAL

Ex- vivo cultured adult allogeneic MSCs

Intervention Type: BIOLOGICAL

Single intraarticular dose of allogeneic MSCs suspended in 2ml Plasmalyte followed by 2ml of Hyaluronan

Plasmalyte-A

Single intraarticular dose of 2ml Plasmalyte

Group Type: PLACEBO_COMPARATOR

Plasmalyte-A

Intervention Type: BIOLOGICAL

Single intraarticular dose of 2ml Plasmalyte followed by 2ml Hyaluronan

Interventions

Ex- vivo cultured adult allogeneic MSCs

Single intraarticular dose of allogeneic MSCs suspended in 2ml Plasmalyte followed by 2ml of Hyaluronan

Intervention Type: BIOLOGICAL

Plasmalyte-A

Single intraarticular dose of 2ml Plasmalyte followed by 2ml Hyaluronan

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Males or females in the age 40 - 70 years (both inclusive)

2. Radiographic evidence of grade 2 to 3 osteoarthritis based on the Kellgren and Lawrence radiographic criteria.

3. History of primary idiopathic osteoarthritis of the knee characterized by pain which requires intake of analgesics.

4. Self-reported difficulty in at least one of the following activities attributed to knee pain: lifting and carrying groceries, walking 400 metres, getting in and out of a chair, or going up and down stairs.

5. Patients who have been on stable medication which may be NSAIDs / Opioid or opiate analgesics, for the past three months.

6. Female patients of childbearing age must be willing to use accepted methods of contraception during the course of the study

7. Ability to provide written informed consent.

Exclusion Criteria

1. Prior or ongoing medical conditions (e.g., concomitant illness, psychiatric condition, alcoholism, drug abuse), medical history, physical findings, ECG findings, or laboratory abnormality that, in the investigator's opinion, could adversely affect the safety of the subject, makes it unlikely that the course of treatment or follow-up would be completed, or could impair the assessment of study results.

2. History of surgery, or major trauma to the study joint

3. Arthroscopy on the study joint in the previous 12 months

4. Signs of active study joint inflammation including redness, warmth, and/or, if qualifying with osteoarthritis of the knee, a large, bulging effusion of the study knee joint with the loss of normal contour of the joint at the screening visit or at the baseline examination

5. Patients who had received intraarticular steroids or hyaluronan within the last three months.

6. Infections in or around the knee.

7. Patients awaiting a replacement knee or hip joint

8. Patients with other conditions that cause pain

9. Patients with deformity of the knee joint.

10. Significantly incapacitated or disabled and would be categorized as ACR Functional Class IV (largely or wholly incapacitated), or unable to walk without assistive devices

11. Patients with other known rheumatic or inflammatory disease such as rheumatoid arthritis

12. Other pathologic lesions on x-rays of knee

13. Positive hepatitis B surface antigen, hepatitis C antibody test, Anti human immunodeficiency virus (HIV) antibody test, or RPR

14. History of Bleeding disorders

15. Known hypersensitivity to Hyaluronan products or animal sera

16. For women of child-bearing potential: positive pregnancy test or lactating [Females who are planning pregnancy within next one year should be excluded]

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stempeutics Research Pvt Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vikas Agarwal, MD., DM

Role: PRINCIPAL_INVESTIGATOR

Department of Immunology Sanjay Gandhi Post Graduate Institute of Medical Sciences

Vivek Pandey, MS

Role: PRINCIPAL_INVESTIGATOR

Department of Orthopedics, Kasturba Medical College

Naresh Shetty, MS

Role: PRINCIPAL_INVESTIGATOR

Department of Orthopedics, M. S. Ramaiah Memorial Hospital

Shrikant Wagh, MD

Role: PRINCIPAL_INVESTIGATOR

Jehangir Hospital

Bhibas Dasgupta, MS

Role: PRINCIPAL_INVESTIGATOR

Seth G. S. Medical College and KEM Hospital

Locations

Department of Orthopedics, M. S. Ramaiah Memorial Hospital

Bangalore, Karnataka, India

Department of Orthopedics, Kasturba Medical College

Manipal, Karnataka, India

Seth G. S. Medical College and KEM Hospital

Mumbai, Maharashtra, India

Jehangir Hospital

Pune, Maharashtra, India

Department of Immunology Sanjay Gandhi Post Graduate Institute of Medical Sciences

Lucknow, Uttar Pradesh, India

Countries

India

References

Gupta PK, Chullikana A, Rengasamy M, Shetty N, Pandey V, Agarwal V, Wagh SY, Vellotare PK, Damodaran D, Viswanathan P, Thej C, Balasubramanian S, Majumdar AS. Efficacy and safety of adult human bone marrow-derived, cultured, pooled, allogeneic mesenchymal stromal cells (Stempeucel(R)): preclinical and clinical trial in osteoarthritis of the knee joint. Arthritis Res Ther. 2016 Dec 20;18(1):301. doi: 10.1186/s13075-016-1195-7.

Reference Type: DERIVED

PMID: 27993154 (View on PubMed)

Other Identifiers

SRPL/OA/09-10/001

Identifier Type: -

Identifier Source: org_study_id