Back to results

Allogeneic Mesenchymal Stem Cells in Osteoarthritis

Primary Purpose

Osteoarthritis of Knee

Status

Completed

Phase

Phase 2

Locations

India

Study Type

Interventional

Intervention

Ex- vivo cultured adult allogeneic MSCs

Plasmalyte-A

About this trial

This is an interventional treatment trial for Osteoarthritis of Knee focused on measuring Osteoarthritis, Knee, Stem cells, Mesenchymal Stem Cells

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Males or females in the age 40 - 70 years (both inclusive)
Radiographic evidence of grade 2 to 3 osteoarthritis based on the Kellgren and Lawrence radiographic 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 which may be NSAIDs / Opioid or opiate analgesics, for the past 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 Criteria:

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, or major trauma to the study joint
Arthroscopy on 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
Patients who had received intraarticular steroids or hyaluronan within the last three months.
Infections in or around the knee.
Patients awaiting a replacement knee or hip joint
Patients with other conditions that cause pain
Patients with deformity of the knee joint.
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 RPR
History of Bleeding disorders
Known hypersensitivity to Hyaluronan products or animal sera
For women of child-bearing potential: positive pregnancy test or lactating [Females who are planning pregnancy within next one year should be excluded]

Sites / Locations

Department of Orthopedics, M. S. Ramaiah Memorial Hospital
Department of Orthopedics, Kasturba Medical College
Seth G. S. Medical College and KEM Hospital
Jehangir Hospital
Department of Immunology Sanjay Gandhi Post Graduate Institute of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ex- vivo cultured adult allogeneic MSCs

Plasmalyte-A

Arm Description

Single intraarticular dose of allogeneic MSCs suspended in 2-4ml Plasmalyte A followed by 2 ml of Hyaluronan

Single intraarticular dose of 2ml Plasmalyte

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Change from baseline in WOMAC OA stiffness index

Change from baseline in WOMAC OA composite index

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

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

Change from baseline in the WORMS score (Whole-Organ Magnetic Resonance Imaging Score) of knee using MRI

Change from baseline in arthritis pain scores on the visual analogue scale

Reduction in the intake of analgesic tablets from baseline

Full Information

NCT ID

NCT01453738

First Posted

October 13, 2011

Last Updated

May 11, 2016

Sponsor

Stempeutics Research Pvt Ltd

1. Study Identification

Unique Protocol Identification Number

NCT01453738

Brief Title

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

2. Study Status

Record Verification Date

May 2016

Overall Recruitment Status

Completed

Study Start Date

November 2011 (undefined)

Primary Completion Date

November 2014 (Actual)

Study Completion Date

November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Stempeutics Research Pvt Ltd

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis of Knee

Keywords

Osteoarthritis, Knee, Stem cells, Mesenchymal Stem Cells

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ex- vivo cultured adult allogeneic MSCs

Arm Type

Experimental

Arm Description

Single intraarticular dose of allogeneic MSCs suspended in 2-4ml Plasmalyte A followed by 2 ml of Hyaluronan

Arm Title

Plasmalyte-A

Arm Type

Placebo Comparator

Arm Description

Single intraarticular dose of 2ml Plasmalyte

Intervention Type

Biological

Intervention Name(s)

Ex- vivo cultured adult allogeneic MSCs

Intervention Description

Single intraarticular dose of allogeneic MSCs suspended in 2ml Plasmalyte followed by 2ml of Hyaluronan

Intervention Type

Biological

Intervention Name(s)

Plasmalyte-A

Intervention Description

Single intraarticular dose of 2ml Plasmalyte followed by 2ml Hyaluronan

Primary Outcome Measure Information:

Title

Number and percentage of patients with adverse events as a measure of safety and tolerability

Description

Time Frame

2 years

Secondary Outcome Measure Information:

Title

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

Time Frame

2 years

Title

Change from baseline in WOMAC OA stiffness index

Time Frame

2 years

Title

Change from baseline in WOMAC OA composite index

Time Frame

2 years

Title

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

Time Frame

2 years

Title

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

Time Frame

2 years

Title

Change from baseline in the WORMS score (Whole-Organ Magnetic Resonance Imaging Score) of knee using MRI

Time Frame

2 years

Title

Change from baseline in arthritis pain scores on the visual analogue scale

Time Frame

2 years

Title

Reduction in the intake of analgesic tablets from baseline

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Males or females in the age 40 - 70 years (both inclusive) Radiographic evidence of grade 2 to 3 osteoarthritis based on the Kellgren and Lawrence radiographic 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 which may be NSAIDs / Opioid or opiate analgesics, for the past 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 Criteria: 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, or major trauma to the study joint Arthroscopy on 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 Patients who had received intraarticular steroids or hyaluronan within the last three months. Infections in or around the knee. Patients awaiting a replacement knee or hip joint Patients with other conditions that cause pain Patients with deformity of the knee joint. 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 RPR History of Bleeding disorders Known hypersensitivity to Hyaluronan products or animal sera For women of child-bearing potential: positive pregnancy test or lactating [Females who are planning pregnancy within next one year should be excluded]

Overall Study Officials: