Allogeneic Mesenchymal Stem Cells in Osteoarthritis

• ClinicalTrials.gov Identifier: NCT01453738
• Recruitment Status: Completed
• First Posted: October 18, 2011
• Last Update Posted: May 12, 2016
• Sponsor: Stempeutics Research Pvt Ltd
• Information provided by (Responsible Party): Stempeutics Research Pvt Ltd

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Osteoarthritis of Knee	Biological: Ex- vivo cultured adult allogeneic MSCs; Biological: Plasmalyte-A	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double Blind, Multicentric, Placebo Controlled, Phase -II Study Assessing the Safety and Efficacy of Intraarticular Ex-vivo Cultured Adult Allogeneic Mesenchymal Stem Cells in Patients With Osteoarthritis of Knee
• Study Start Date: November 2011
• Actual Primary Completion Date: November 2014
• Actual Study Completion Date: November 2014

Arms and Interventions

Arm	Intervention/treatment
Experimental: Ex- vivo cultured adult allogeneic MSCs; Single intraarticular dose of allogeneic MSCs suspended in 2-4ml Plasmalyte A followed by 2 ml of Hyaluronan	Biological: Ex- vivo cultured adult allogeneic MSCs; Single intraarticular dose of allogeneic MSCs suspended in 2ml Plasmalyte followed by 2ml of Hyaluronan
Placebo Comparator: Plasmalyte-A; Single intraarticular dose of 2ml Plasmalyte	Biological: Plasmalyte-A; Single intraarticular dose of 2ml Plasmalyte followed by 2ml Hyaluronan

Outcome Measures

Primary Outcome Measures :

1. Number and percentage of patients with adverse events as a measure of safety and tolerability [ Time Frame: 2 years ]
   • Safety evaluation will include assessment of physical examination, periodic monitoring of vital signs (heart rate, respiratory rate, blood pressure and temperature), clinical laboratory investigations (including haematology, serum chemistry, LFT, urine-analysis) and 12-lead ECG recording.
   • Tolerability: Adverse events monitored using information volunteered by the patients and as observed by the PI will be summarized descriptively by total number of AE(s) and compared between the study arms.

Secondary Outcome Measures :

1. Change from baseline in the WOMAC OA (Western Ontario and McMaster Universities Osteoarthritis) Index -pain subscale score [ Time Frame: 2 years ]
2. Change from baseline in WOMAC OA stiffness index [ Time Frame: 2 years ]
3. Change from baseline in WOMAC OA composite index [ Time Frame: 2 years ]
4. Change from baseline in ICOAP (Intermittent and Constant Osteoarthritis Pain) [ Time Frame: 2 years ]
5. Change from baseline in radiographic (X-ray) findings of knee [ Time Frame: 2 years ]
6. Change from baseline in the WORMS score (Whole-Organ Magnetic Resonance Imaging Score) of knee using MRI [ Time Frame: 2 years ]
7. Change from baseline in arthritis pain scores on the visual analogue scale [ Time Frame: 2 years ]
8. Reduction in the intake of analgesic tablets from baseline [ Time Frame: 2 years ]

Eligibility Criteria

• 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. 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]

Contacts and Locations

Locations

India

Department of Orthopedics, M. S. Ramaiah Memorial Hospital

Bangalore, Karnataka, India, 560054

Department of Orthopedics, Kasturba Medical College

Manipal, Karnataka, India, 576 104

Seth G. S. Medical College and KEM Hospital

Mumbai, Maharashtra, India, 400012

Jehangir Hospital

Pune, Maharashtra, India, 411001

Department of Immunology Sanjay Gandhi Post Graduate Institute of Medical Sciences

Lucknow, Uttar Pradesh, India, 226 014

Sponsors and Collaborators

Stempeutics Research Pvt Ltd

Investigators

• Principal Investigator: Vikas Agarwal, MD., DM; Department of Immunology Sanjay Gandhi Post Graduate Institute of Medical Sciences
• Principal Investigator: Vivek Pandey, MS; Department of Orthopedics, Kasturba Medical College
• Principal Investigator: Naresh Shetty, MS; Department of Orthopedics, M. S. Ramaiah Memorial Hospital
• Principal Investigator: Shrikant Wagh, MD; Jehangir Hospital
• Principal Investigator: Bhibas Dasgupta, MS; Seth G. S. Medical College and KEM Hospital

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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®): preclinical and clinical trial in osteoarthritis of the knee joint. Arthritis Res Ther. 2016 Dec 20;18(1):301.

• Responsible Party: Stempeutics Research Pvt Ltd
• ClinicalTrials.gov Identifier: NCT01453738
• Other Study ID Numbers: SRPL/OA/09-10/001
• First Posted: October 18, 2011
• Last Update Posted: May 12, 2016
• Last Verified: May 2016

Keywords provided by Stempeutics Research Pvt Ltd:

Osteoarthritis; Knee; Stem cells; Mesenchymal Stem Cells

Additional relevant MeSH terms:

Osteoarthritis; Osteoarthritis, Knee; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Plasma-lyte 148; Ophthalmic Solutions; Pharmaceutical Solutions