Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Allogeneic Mesenchymal Stem Cells in Osteoarthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01453738
Recruitment Status : Completed
First Posted : October 18, 2011
Last Update Posted : May 12, 2016
Sponsor:
Information provided by (Responsible Party):
Stempeutics Research Pvt Ltd

Tracking Information
First Submitted Date  ICMJE October 13, 2011
First Posted Date  ICMJE October 18, 2011
Last Update Posted Date May 12, 2016
Study Start Date  ICMJE November 2011
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 17, 2011)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 17, 2011)
  • Change from baseline in the WOMAC OA (Western Ontario and McMaster Universities Osteoarthritis) Index -pain subscale score [ Time Frame: 2 years ]
  • Change from baseline in WOMAC OA stiffness index [ Time Frame: 2 years ]
  • Change from baseline in WOMAC OA composite index [ Time Frame: 2 years ]
  • Change from baseline in ICOAP (Intermittent and Constant Osteoarthritis Pain) [ Time Frame: 2 years ]
  • Change from baseline in radiographic (X-ray) findings of knee [ Time Frame: 2 years ]
  • Change from baseline in the WORMS score (Whole-Organ Magnetic Resonance Imaging Score) of knee using MRI [ Time Frame: 2 years ]
  • Change from baseline in arthritis pain scores on the visual analogue scale [ Time Frame: 2 years ]
  • Reduction in the intake of analgesic tablets from baseline [ Time Frame: 2 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Allogeneic Mesenchymal Stem Cells in Osteoarthritis
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis of Knee
Intervention  ICMJE
  • Biological: Ex- vivo cultured adult allogeneic MSCs
    Single intraarticular dose of allogeneic MSCs suspended in 2ml Plasmalyte followed by 2ml of Hyaluronan
  • Biological: Plasmalyte-A
    Single intraarticular dose of 2ml Plasmalyte followed by 2ml Hyaluronan
Study Arms  ICMJE
  • 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
    Intervention: Biological: Ex- vivo cultured adult allogeneic MSCs
  • Placebo Comparator: Plasmalyte-A
    Single intraarticular dose of 2ml Plasmalyte
    Intervention: Biological: Plasmalyte-A
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 17, 2011)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2014
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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]
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01453738
Other Study ID Numbers  ICMJE SRPL/OA/09-10/001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Stempeutics Research Pvt Ltd
Study Sponsor  ICMJE Stempeutics Research Pvt Ltd
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Stempeutics Research Pvt Ltd
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP