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Osteoarthritis of KneePhase 2NCT01453738

Allogeneic Mesenchymal Stem Cells in Osteoarthritis

A Phase 2 study testing Ex- vivo cultured adult allogeneic MSCs and Plasmalyte-A in people with Osteoarthritis of Knee, run by Stempeutics Research Pvt Ltd at 5 sites in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 70 years
Conditions the study is for
Osteoarthritis of Knee
What is being tested?
Ex- vivo cultured adult allogeneic MSCs and Plasmalyte-A
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
5 sitesIndia
Study dates
Nov 2011to Nov 2014
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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]

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

India5 sites

  • Department of Orthopedics, M. S. Ramaiah Memorial Hospital

    Bangalore, Karnataka, 560054

  • Department of Immunology Sanjay Gandhi Post Graduate Institute of Medical Sciences

    Lucknow, Uttar Pradesh, 226 014

  • Department of Orthopedics, Kasturba Medical College

    Manipal, Karnataka, 576 104

  • Seth G. S. Medical College and KEM Hospital

    Mumbai, Maharashtra, 400012

  • Jehangir Hospital

    Pune, Maharashtra, 411001

Other trials in India

About this study

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

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.

Being tested
Ex- vivo cultured adult allogeneic MSCs, Plasmalyte-A
Keywords
Osteoarthritis, Knee, Stem cells, Mesenchymal Stem Cells
Medical subject headings
Osteoarthritis, Knee, Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ex- vivo cultured adult allogeneic MSCsBiological

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

  • Plasmalyte-ABiological

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

Study groups in NCT01453738
Study groupRoleWhat they receive
Ex- vivo cultured adult allogeneic MSCsExperimentalSingle intraarticular dose of allogeneic MSCs suspended in 2-4ml Plasmalyte A followed by 2 ml of Hyaluronan
Receives: Biological: Ex- vivo cultured adult allogeneic MSCs
Plasmalyte-APlacebo comparatorSingle intraarticular dose of 2ml Plasmalyte
Receives: Biological: Plasmalyte-A

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 2 years

Secondary outcomes (8)

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

    Measured: 2 years

  2. Change from baseline in WOMAC OA stiffness index

    Measured: 2 years

  3. Change from baseline in WOMAC OA composite index

    Measured: 2 years

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

    Measured: 2 years

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

    Measured: 2 years

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

    Measured: 2 years

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

    Measured: 2 years

  8. Reduction in the intake of analgesic tablets from baseline

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Oct 2011 (estimated)
  2. Study startNov 2011
  3. Primary completionNov 2014
  4. Study completionNov 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01453738
Sponsor's protocol ID
SRPL/OA/09-10/001
Status last verified
May 2016
First submitted
13 Oct 2011
Last updated
12 May 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 27993154

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ex- vivo cultured adult allogeneic MSCs and Plasmalyte-A in people with Osteoarthritis of Knee, run by Stempeutics Research Pvt Ltd at 5 sites in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number and percentage of patients with adverse events as a measure of safety and tolerability (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01453738, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2016; AzTrials last refreshed its copy on 1 Nov 2026.

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