Allogeneic Mesenchymal Stem Cells for Osteoarthritis

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Stempeutics Research Malaysia SDN BHD
Information provided by (Responsible Party):
Stempeutics Research Pvt Ltd
ClinicalTrials.gov Identifier:
NCT01448434
First received: September 20, 2011
Last updated: October 1, 2012
Last verified: October 2012
  Purpose

This study is designed to know the safety and efficacy of 2 different doses of mesenchymal stem cells in patients suffering from osteoarthritis of knee joint.


Condition Intervention Phase
Osteoarthritis of Knee Joint
Biological: Ex- vivo cultured adult allogeneic MSCs
Biological: Plasmalyte-A
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Stempeutics Research Pvt Ltd:

Primary Outcome Measures:
  • Number and percentage of patients with adverse events as a measure of safety and tolerability [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    • 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:
  • Change from baseline in the WOMAC OA (Western Ontario and McMaster Universities Osteoarthritis) Index -pain subscale score [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
  • Change from baseline in WOMAC OA stiffness index [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
  • Change from baseline in WOMAC OA composite index [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
  • Change from baseline in ICOAP (Intermittent and Constant Osteoarthritis Pain) [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
  • Change from baseline in radiographic (X-ray) findings of knee [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
  • Change from baseline in the WORMS score of knee using MRI [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
  • Change from baseline in arthritis pain scores on the visual analogue scale [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
  • Reduction in the intake of analgesic tablets from baseline [ Time Frame: 1 Year ] [ Designated as safety issue: No ]

Estimated Enrollment: 72
Study Start Date: September 2011
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ex- vivo cultured adult allogeneic MSCs
Single intraarticular dose of allogeneic MSCs
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

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males or females in the age 20 - 70 years (both inclusive)
  2. Radiographic evidence of grade 2 to 3 osteoarthritis based on the Kellgren and Lawrence radiographic entry 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 for the past three months.
  6. Patients who have not received intra articular steroids or hyaluronan within the last three months.
  7. Female patients of childbearing age must be willing to use accepted methods of contraception during the course of the study
  8. 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, including arthroscopy, or major trauma to the study joint in the previous 12 months
  3. 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
  4. Infections in or around the knee.
  5. Patients awaiting a replacement knee or hip joint
  6. Patients with other conditions that cause pain
  7. Significantly incapacitated or disabled and would be categorized as ACR Functional Class IV (largely or wholly incapacitated), or unable to walk without assistive devices
  8. Patients with other known rheumatic or inflammatory disease such as rheumatoid arthritis
  9. Other pathologic lesions on x-rays of knee
  10. Positive hepatitis B surface antigen, hepatitis C antibody test, Anti human immunodeficiency virus (HIV) antibody test, or VDRL
  11. History of Bleeding disorders
  12. Known hypersensitivity to Hyaluronan products or animal sera
  13. For women of child-bearing potential: positive pregnancy test or lactating
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01448434

Locations
Malaysia
Pantai Cheras Medical Centre
Kuala Lumpur, Federal territory, Malaysia, 56100
KPJ Ampang Puteri Specialist Hospital
Kuala Lumpur, Selangor, Malaysia, 68000
Serdang Hospital
Kuala Lumpur, Selangor, Malaysia, 43300
Selayang Hospital
Kuala Lumpur, Selangor, Malaysia, 68100
Sponsors and Collaborators
Stempeutics Research Pvt Ltd
Stempeutics Research Malaysia SDN BHD
Investigators
Principal Investigator: Prof. Dr. Muhammad Ali Noor Muhd Abdul Ghani, FRCS KPJ Ampang Puteri Specialist Hospital
Principal Investigator: Dr. Ahmad Hisham Abd. Rashid, MD., MS Serdang Hospital
Principal Investigator: Dr. Suntharalingam Subramaniam, FRCS Pantai Cheras Medical Centre
Principal Investigator: Dato' Dr. Ramli Baba, MS Selayang Hospital
  More Information

No publications provided

Responsible Party: Stempeutics Research Pvt Ltd
ClinicalTrials.gov Identifier: NCT01448434     History of Changes
Other Study ID Numbers: SRM/OA/10-11/001
Study First Received: September 20, 2011
Last Updated: October 1, 2012
Health Authority: Malaysia: Ministry of Health

Keywords provided by Stempeutics Research Pvt Ltd:
Osteoarthritis
Knee
Stem cell
MSC

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Plasma-lyte 148
Ophthalmic Solutions
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 20, 2014