Clinical trial NCT01453738: Allogeneic Mesenchymal Stem Cells in 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
Keywords: Osteoarthritis
Knee
Stem cells
Mesenchymal Stem Cells
Lead sponsor: Stempeutics Research Pvt Ltd
Sponsor class: INDUSTRY
First posted: 2011-10-18
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 \[Females who are planning pregnancy within next one year should be excluded\]

Primary outcomes:
measure: Number and percentage of patients with adverse events as a measure of safety and tolerability
timeFrame: 2 years
Secondary outcomes:
measure: Change from baseline in the WOMAC OA (Western Ontario and McMaster Universities Osteoarthritis) Index -pain subscale score
timeFrame: 2 years
measure: Change from baseline in WOMAC OA stiffness index
timeFrame: 2 years
measure: Change from baseline in WOMAC OA composite index
timeFrame: 2 years
measure: Change from baseline in ICOAP (Intermittent and Constant Osteoarthritis Pain)
timeFrame: 2 years
measure: Change from baseline in radiographic (X-ray) findings of knee
timeFrame: 2 years
measure: Change from baseline in the WORMS score (Whole-Organ Magnetic Resonance Imaging Score) of knee using MRI
timeFrame: 2 years
measure: Change from baseline in arthritis pain scores on the visual analogue scale
timeFrame: 2 years
measure: Reduction in the intake of analgesic tablets from baseline
timeFrame: 2 years
Other outcomes:
Locations:
city: Bangalore
country: India
facility: Department of Orthopedics, M. S. Ramaiah Memorial Hospital
state: Karnataka
city: Manipal
country: India
facility: Department of Orthopedics, Kasturba Medical College
state: Karnataka
city: Mumbai
country: India
facility: Seth G. S. Medical College and KEM Hospital
state: Maharashtra
city: Pune
country: India
facility: Jehangir Hospital
state: Maharashtra
city: Lucknow
country: India
facility: Department of Immunology Sanjay Gandhi Post Graduate Institute of Medical Sciences
state: Uttar Pradesh
Study officials:
affiliation: Department of Immunology Sanjay Gandhi Post Graduate Institute of Medical Sciences
name: Vikas Agarwal, MD., DM
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Orthopedics, Kasturba Medical College
name: Vivek Pandey, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Orthopedics, M. S. Ramaiah Memorial Hospital
name: Naresh Shetty, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Jehangir Hospital
name: Shrikant Wagh, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Seth G. S. Medical College and KEM Hospital
name: Bhibas Dasgupta, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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(R)): preclinical and clinical trial in osteoarthritis of the knee joint. Arthritis Res Ther. 2016 Dec 20;18(1):301. doi: 10.1186/s13075-016-1195-7.