Status:
COMPLETED
Allogeneic Mesenchymal Stem Cells for Osteoarthritis
Lead Sponsor:
Stempeutics Research Pvt Ltd
Collaborating Sponsors:
Stempeutics Research Malaysia SDN BHD
Conditions:
Osteoarthritis of Knee Joint
Eligibility:
All Genders
20-70 years
Phase:
PHASE2
Brief Summary
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.
Eligibility Criteria
Inclusion
- Males or females in the age 20 - 70 years (both inclusive)
- Radiographic evidence of grade 2 to 3 osteoarthritis based on the Kellgren and Lawrence radiographic entry 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 for the past three months.
- Patients who have not received intra articular steroids or hyaluronan within the last 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.
Exclusion
- 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, including arthroscopy, or major trauma to 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
- Infections in or around the knee.
- Patients awaiting a replacement knee or hip joint
- Patients with other conditions that cause pain
- 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 VDRL
- History of Bleeding disorders
- Known hypersensitivity to Hyaluronan products or animal sera
- For women of child-bearing potential: positive pregnancy test or lactating
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT01448434
Start Date
September 1 2011
End Date
September 1 2013
Last Update
May 12 2016
Active Locations (4)
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1
Pantai Cheras Medical Centre
Kuala Lumpur, Kuala Lumpur, Malaysia, 56100
2
Serdang Hospital
Kuala Lumpur, Selangor, Malaysia, 43300
3
KPJ Ampang Puteri Specialist Hospital
Kuala Lumpur, Selangor, Malaysia, 68000
4
Selayang Hospital
Kuala Lumpur, Selangor, Malaysia, 68100