Allogeneic Mesenchymal Stem Cells for Osteoarthritis

NCT01448434 | Completed Phase 2 DMC

• 1 other identifier: SRM/OA/10-11/001
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 4

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.

Conditions

Osteoarthritis of Knee Joint

Keywords

Osteoarthritis; Knee; Stem cell; MSC

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.

  1 year

Secondary Outcomes (8)

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

  1 Year

• Change from baseline in WOMAC OA stiffness index

  1 Year

• Change from baseline in WOMAC OA composite index

  1 Year

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

  1 Year

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

  1 Year

Study Arms (2)

Ex- vivo cultured adult allogeneic MSCs

EXPERIMENTAL

Single intraarticular dose of allogeneic MSCs

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: 20 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 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.

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, 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

Sponsors & Collaborators

• Stempeutics Research Pvt Ltd: lead
• Stempeutics Research Malaysia SDN BHD: collaborator

Study Sites (4)

Pantai Cheras Medical Centre

Kuala Lumpur, Kuala Lumpur, 56100, Malaysia

Location

Serdang Hospital

Kuala Lumpur, Selangor, 43300, Malaysia

Location

KPJ Ampang Puteri Specialist Hospital

Kuala Lumpur, Selangor, 68000, Malaysia

Location

Selayang Hospital

Kuala Lumpur, Selangor, 68100, Malaysia

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Plasmalyte A

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Prof. Dr. Muhammad Ali Noor Muhd Abdul Ghani, FRCS

  KPJ Ampang Puteri Specialist Hospital

  PRINCIPAL INVESTIGATOR

• Dr. Ahmad Hisham Abd. Rashid, MD., MS

  Clinical Research Centre Hospital Serdang

  PRINCIPAL INVESTIGATOR

• Dr. Suntharalingam Subramaniam, FRCS

  Pantai Cheras Medical Centre

  PRINCIPAL INVESTIGATOR

• Dato' Dr. Ramli Baba, MS

  Selayang 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: September 20, 2011
• First Posted: October 7, 2011
• Study Start: September 1, 2011
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: May 12, 2016

Record last verified: 2016-05

Locations

MY (4)