Clinical trial NCT01448434: Allogeneic Mesenchymal Stem Cells for Osteoarthritis
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoarthritis of Knee Joint
Keywords: Osteoarthritis
Knee
Stem cell
MSC
Lead sponsor: Stempeutics Research Pvt Ltd
Sponsor class: INDUSTRY
Collaborators: name: Stempeutics Research Malaysia SDN BHD
First posted: 2011-10-07
Enrollment: 72
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Number and percentage of patients with adverse events as a measure of safety and tolerability
timeFrame: 1 year
Secondary outcomes:
measure: Change from baseline in the WOMAC OA (Western Ontario and McMaster Universities Osteoarthritis) Index -pain subscale score
timeFrame: 1 Year
measure: Change from baseline in WOMAC OA stiffness index
timeFrame: 1 Year
measure: Change from baseline in WOMAC OA composite index
timeFrame: 1 Year
measure: Change from baseline in ICOAP (Intermittent and Constant Osteoarthritis Pain)
timeFrame: 1 Year
measure: Change from baseline in radiographic (X-ray) findings of knee
timeFrame: 1 Year
measure: Change from baseline in the WORMS score of knee using MRI
timeFrame: 1 Year
measure: Change from baseline in arthritis pain scores on the visual analogue scale
timeFrame: 1 Year
measure: Reduction in the intake of analgesic tablets from baseline
timeFrame: 1 Year
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: Pantai Cheras Medical Centre
state: Federal territory
city: Kuala Lumpur
country: Malaysia
facility: Serdang Hospital
state: Selangor
city: Kuala Lumpur
country: Malaysia
facility: KPJ Ampang Puteri Specialist Hospital
state: Selangor
city: Kuala Lumpur
country: Malaysia
facility: Selayang Hospital
state: Selangor
Study officials:
affiliation: KPJ Ampang Puteri Specialist Hospital
name: Prof. Dr. Muhammad Ali Noor Muhd Abdul Ghani, FRCS
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Research Centre Hospital Serdang
name: Dr. Ahmad Hisham Abd. Rashid, MD., MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Pantai Cheras Medical Centre
name: Dr. Suntharalingam Subramaniam, FRCS
role: PRINCIPAL_INVESTIGATOR
affiliation: Selayang Hospital
name: Dato' Dr. Ramli Baba, MS
role: PRINCIPAL_INVESTIGATOR
References: