Alcoholic Liver CirrhosisPhase 2NCT01591200
Dose Finding Study to Assess Safety and Efficacy of Stem Cells in Liver Cirrhosis
A Phase 2 study testing Allogeneic Mesenchymal Stem Cells in people with Alcoholic Liver Cirrhosis, run by Stempeutics Research Pvt Ltd at 10 sites in India.
Trial summary
This study will evaluate the safety and efficacy of mesenchymal stem cells in patients with cirrhosis of liver. Stem cells will be injected into the hepatic artery. Improvement in various parameters will be observed over 2 years. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alcoholic Liver Cirrhosis
- What is being tested?
- Allogeneic Mesenchymal Stem Cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 10 sitesIndia
- Study dates
- Jun 2012to Apr 2016
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Alcoholic cirrhotics between 18-65 years of age (diagnosed by clinical, biochemical, sonographic, radiological [CT scan] or histological evidence of cirrhosis and portal hypertension).
- Evidence of decompensated liver disease at screening (e.g. Child class B or C, Child-Pugh scores of ≥7 and <14).
- MELD scores of at least 10 (UNOS Meld calculator).
- Normal AFP Level
- Hb>10gm/dl.
- Female patients of childbearing age must be willing to use accepted methods of contraception during the course of the study
- Signed informed consent.
Who cannot join
- Patients likely to undergo liver transplantation during the duration of the study.
- Presence of advanced hepatic encephalopathy Grades 3 \& 4 (West Haven criteria for grading of hepatic encephalopathy) at the time of screening
- Active variceal bleed.
- Refractory ascites.
- Evidences of autoimmune liver disease- ANA or Anti-LKM positivity.
- Platelet count < 30,000/mm3.
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- Serum Sodium <129mEq/L.
- Serum Creatinine > 2 mg/dl.
- Hepatocellular carcinoma or other malignancies
- Active infectious disease.
- Presence of severe underlying cardiac, pulmonary or renal disease.
- Excessive alcohol (>30 gm of alcohol/day) use in the last 3 months before screening.
- Positive HbSAg or antibodies to HIV or HCV.
- Pregnancy or lactation.
- Participation in other clinical trials.
- Unwilling/unable to sign the informed consent.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
India10 sites
Manipal Hospital
Bangalore, Karnataka, 560017
Centre for Liver Research & Diagnostics
Hyderabad, Andhra Pradesh, 500058
Mediciti Hospital
Hyderabad, Andhra Pradesh, 500063
SMS Medical college and Hospital
Jaipur, Rajasthan, 302004
SGPGI Lucknow
Lucknow, Uttar Pradesh, 226014
KMC Hospital
Mangalore, Karnataka, 575001
Institute of liver disease, HPB surgery and transplant Global Hospitals
Mumbai, Maharashtra, 400012
Bombay Hospital & Medical Research Center
Mumbai, Maharashtra, 400020
Ruby Hall clinic
Pune, Maharashtra, 411001
Sahyadri Speciality Hospital
Pune, Maharashtra, 411004
About this study
Official title: A Parallel Group Randomized Open Blinded End Point Evaluation, Multicentric, Dose Escalation, Phase -II Study Assessing the Safety and Efficacy of Intraarterial (Hepatic) Ex-vivo Cultured Adult Allogenic Mesenchymal Stem Cells in Patients With Alcoholic Liver Cirrhosis
This study will evaluate the safety and efficacy of mesenchymal stem cells in patients with cirrhosis of liver. Stem cells will be injected into the hepatic artery. Improvement in various parameters will be observed over 2 years.
- Conditions
- Alcoholic Liver Cirrhosis
- Being tested
- Allogeneic Mesenchymal Stem Cells
- Keywords
- Alcoholic, Liver, Cirrhosis, Stem, Cells
- Medical subject headings
- Liver Cirrhosis, Alcoholic, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allogeneic Mesenchymal Stem CellsBiological
High dose of Bone Marrow Derived Allogeneic Mesenchymal Stem Cells will be administered through the hepatic artery
Allogeneic Mesenchymal Stem CellsBiological
Intermediate dose of Bone Marrow Derived Allogeneic Mesenchymal Stem Cells will be administered through the hepatic artery
Allogeneic Mesenchymal Stem CellsBiological
Low dose of Bone Marrow Derived Allogeneic Mesenchymal Stem Cells will be administered through the hepatic artery
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | This arm will receive standard protocol of care alone |
| Stem cells high dose | Experimental | This arm will receive high dose of Allogeneic Mesenchymal Stem Cells Receives: Biological: Allogeneic Mesenchymal Stem Cells |
| Stem cells intermediate dose | Experimental | This arm will receive intermediate dose of Allogeneic Mesenchymal Stem Cells Receives: Biological: Allogeneic Mesenchymal Stem Cells |
| Stem cells low dose | Experimental | This arm will receive low dose of Allogeneic Mesenchymal Stem Cells Receives: Biological: Allogeneic Mesenchymal Stem Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
The type of adverse events, number of adverse events and proportion of patients with adverse events
Measured: 2 years
Secondary outcomes (6)
Liver function tests.
To assess the improvement in liver function
Measured: 2 years
CT scan of abdomen.
To assess the improvement in liver structure
Measured: 2 years
Change in MELD score
To assess the clinical improvement
Measured: 2 years
Improvement in quality of life as assessed by SF 36 questionnaire
To assess the improvement in quality of life
Measured: 2 years
Histological evaluation of liver biopsy by immunohistochemical staining for AFP, PCNA, SMA
To assess the improvement in histopathology
Measured: 6 Months
Change in Child-Pugh score
To assess clinical improvement
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2012 (estimated)
- Study startJun 2012
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcoholic Liver CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stempeutics Research Pvt Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. BV Tantry, MD., DM, Principal investigator, KMC, MangaloreDr. Samir Shah, MD., DM, Principal investigator, Breach Candy Hospital, MumbaiDr. Dinesh Kini, MD., DM, Principal investigator, Manipal Hospital, IndiaDr.Deepak N Amarapuraka, MD., DM, Principal investigator, Bombay Hospital & Medical Research Center, MumbaiDr. VA Saraswat, MD., DM, Principal investigator, SGPGI, KucknowDr. Aejaz Habeeb, MD., DM, Principal investigator, Centre for Liver Research & Diagnostics, HyderabadDr Uma Devi, MD, Principal investigator, Mediciti HospitalDr Sanjay Kolte Kolte, DNB., FCPS, Principal investigator, Sahyadri Speciality Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01591200
- Sponsor's protocol ID
- SRPL/LC/09-10/001
- Status last verified
- Sep 2016
- First submitted
- 15 Apr 2012
- Last updated
- 15 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Parallel Group Randomized Open Blinded End Point Evaluation, Multicentric, Dose Escalation, Phase -II Study Assessing the Safety and Efficacy of Intraarterial (Hepatic) Ex-vivo Cultured Adult Allogenic Mesenchymal Stem Cells in Patients With Alcoholic Liver Cirrhosis
- ClinicalTrials.gov ID
- NCT01591200
- Acronym / sponsor ID
- SRPL/LC/09-10/001
- Conditions
- Alcoholic Liver Cirrhosis
- Keywords
- Alcoholic, Liver, Cirrhosis, Stem, Cells
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Stempeutics Research Pvt LtdIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 3 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the safety and efficacy of mesenchymal stem cells in patients with cirrhosis of liver. Stem cells will be injected into the hepatic artery. Improvement in various parameters will be observed over 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –This arm will receive standard protocol of care alone |
| Stem cells high dose | Experimental | Biological: Allogeneic Mesenchymal Stem CellsThis arm will receive high dose of Allogeneic Mesenchymal Stem Cells |
| Stem cells intermediate dose | Experimental | Biological: Allogeneic Mesenchymal Stem CellsThis arm will receive intermediate dose of Allogeneic Mesenchymal Stem Cells |
| Stem cells low dose | Experimental | Biological: Allogeneic Mesenchymal Stem CellsThis arm will receive low dose of Allogeneic Mesenchymal Stem Cells |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Alcoholic cirrhotics between 18-65 years of age (diagnosed by clinical, biochemical, sonographic, radiological [CT scan] or histological evidence of cirrhosis and portal hypertension).
- Evidence of decompensated liver disease at screening (e.g. Child class B or C, Child-Pugh scores of ≥7 and <14).
- MELD scores of at least 10 (UNOS Meld calculator).
- Normal AFP Level
- Hb>10gm/dl.
Key exclusion criteria (16 listed)
- Patients likely to undergo liver transplantation during the duration of the study.
- Presence of advanced hepatic encephalopathy Grades 3 \& 4 (West Haven criteria for grading of hepatic encephalopathy) at the time of screening
- Active variceal bleed.
- Refractory ascites.
- Evidences of autoimmune liver disease- ANA or Anti-LKM positivity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Allogeneic Mesenchymal Stem CellsHigh dose of Bone Marrow Derived Allogeneic Mesenchymal Stem Cells will be administered through the hepatic artery | Biological | Stem cells high dose |
| Allogeneic Mesenchymal Stem CellsIntermediate dose of Bone Marrow Derived Allogeneic Mesenchymal Stem Cells will be administered through the hepatic artery | Biological | Stem cells intermediate dose |
| Allogeneic Mesenchymal Stem CellsLow dose of Bone Marrow Derived Allogeneic Mesenchymal Stem Cells will be administered through the hepatic artery | Biological | Stem cells low dose |
Primary outcome
Safety
Time frame: 2 years
The type of adverse events, number of adverse events and proportion of patients with adverse events
6 secondary outcomes
Liver function tests.
Time frame: 2 years
CT scan of abdomen.
Time frame: 2 years
Change in MELD score
Time frame: 2 years
Improvement in quality of life as assessed by SF 36 questionnaire
Time frame: 2 years
Histological evaluation of liver biopsy by immunohistochemical staining for AFP, PCNA, SMA
Time frame: 6 Months
Change in Child-Pugh score
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. BV Tantry, MD., DM principal investigator
KMC, Mangalore
Dr. Samir Shah, MD., DM principal investigator
Breach Candy Hospital, Mumbai
Dr. Dinesh Kini, MD., DM principal investigator
Manipal Hospital, India
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Allogeneic Mesenchymal Stem Cells in people with Alcoholic Liver Cirrhosis, run by Stempeutics Research Pvt Ltd at 10 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 15 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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. 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?
Safety (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Sep 2016.