Allogeneic Mesenchymal Stem Cells in Osteoarthritis

NCT01453738 | Completed Phase 2 DMC

• 1 other identifier: SRPL/OA/09-10/001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 5

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

Keywords

Osteoarthritis; Knee; Stem cells; Mesenchymal Stem Cells

Outcome Measures

Primary Outcomes (1)

• Number and percentage of patients with adverse events as a measure of safety and tolerability

  * 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.

  2 years

Secondary Outcomes (8)

• Change from baseline in the WOMAC OA (Western Ontario and McMaster Universities Osteoarthritis) Index -pain subscale score

  2 years

• Change from baseline in WOMAC OA stiffness index

  2 years

• Change from baseline in WOMAC OA composite index

  2 years

• Change from baseline in ICOAP (Intermittent and Constant Osteoarthritis Pain)

  2 years

• Change from baseline in radiographic (X-ray) findings of knee

  2 years

Study Arms (2)

Ex- vivo cultured adult allogeneic MSCs

EXPERIMENTAL

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

Plasmalyte-A

PLACEBO COMPARATOR

Single intraarticular dose of 2ml Plasmalyte

Biological: Plasmalyte-A

Interventions

Ex- vivo cultured adult allogeneic MSCs BIOLOGICAL

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

Ex- vivo cultured adult allogeneic MSCs

Plasmalyte-A BIOLOGICAL

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

Plasmalyte-A

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females in the age 40 - 70 years (both inclusive)
• Radiographic evidence of grade 2 to 3 osteoarthritis based on the Kellgren and Lawrence radiographic criteria.
• History of primary idiopathic osteoarthritis of the knee characterized by pain which requires intake of analgesics.
• 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.
• Patients who have been on stable medication which may be NSAIDs / Opioid or opiate analgesics, for the past three months.
• Female patients of childbearing age must be willing to use accepted methods of contraception during the course of the study
• Ability to provide written informed consent.

You may not qualify if:

• 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.
• History of surgery, or major trauma to the study joint
• Arthroscopy on the study joint in the previous 12 months
• 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
• Patients who had received intraarticular steroids or hyaluronan within the last three months.
• Infections in or around the knee.
• Patients awaiting a replacement knee or hip joint
• Patients with other conditions that cause pain
• Patients with deformity of the knee joint.
• Significantly incapacitated or disabled and would be categorized as ACR Functional Class IV (largely or wholly incapacitated), or unable to walk without assistive devices
• Patients with other known rheumatic or inflammatory disease such as rheumatoid arthritis
• Other pathologic lesions on x-rays of knee
• Positive hepatitis B surface antigen, hepatitis C antibody test, Anti human immunodeficiency virus (HIV) antibody test, or RPR
• History of Bleeding disorders
• Known hypersensitivity to Hyaluronan products or animal sera

Sponsors & Collaborators

• Stempeutics Research Pvt Ltd: lead

Study Sites (5)

Department of Orthopedics, M. S. Ramaiah Memorial Hospital

Bangalore, Karnataka, 560054, India

Location

Department of Orthopedics, Kasturba Medical College

Manipal, Karnataka, 576 104, India

Location

Seth G. S. Medical College and KEM Hospital

Mumbai, Maharashtra, 400012, India

Location

Jehangir Hospital

Pune, Maharashtra, 411001, India

Location

Department of Immunology Sanjay Gandhi Post Graduate Institute of Medical Sciences

Lucknow, Uttar Pradesh, 226 014, India

Location

Related Publications (1)

• 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.

  PMID: 27993154 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Interventions

Plasmalyte A

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2011
• First Posted: October 18, 2011
• Study Start: November 1, 2011
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: May 12, 2016

Record last verified: 2016-05

Locations

IN (5)