A Phase 1/2 interventional study of Intramyocardial injection of stem cell and Placebo in Heart Failure, sponsored by SCARM Institute, Tabriz, Iran. Status unknown at 1 site in Iran, Islamic Republic of. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-10-27.
Sponsored by SCARM Institute, Tabriz, Iran · Phase 1/2, Interventional, and Treatment
Among 10 studies in Heart Failure with a site in Iran, Islamic Republic of — 1 open to participants now, 1 under way, 1 of them phase 3. Heart Failure · Iran, Islamic Republic of.
Among the 10 studies in Heart Failure with a site in Iran, Islamic Republic of, this one is the 10th largest by planned enrollment, is the only one that started in 2020, is the only one in phase 1/2, and was the 5th registered.
6,332 studies on the registry are indexed under Heart Failure; 1,392 are open to participants now.
Browse Heart Failure studies →1 of the 10 studies in Heart Failure with a site in Iran, Islamic Republic of is open now. Recruiting first, the newest first:
Tehran University of Medical Sciences · Sites in Iran, Islamic Republic of
Ages 18+
A study can be open while its sites in Iran, Islamic Republic of have not opened yet or have stopped. Only those recruiting at a site in Iran, Islamic Republic of →
Of the 966 Heart Failure studies recruiting now, 689 (71%) set no upper age limit and 89 (9%) stop at 75 or younger; 63 take children under 18; 96 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
10 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 3 · Phase 3 3
First in 2008; this study’s year is marked. 1 started in 2020.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 5 is below the median of 76 across 4,049 interventional studies indexed under Heart Failure.
Median enrollment 60 across the 10 interventional studies. Of the 4 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
None of the 10 has an industry lead sponsor. The 8 most frequent:
SCARM Institute, Tabriz, Iran is the lead sponsor of 7 studies on the registry; none are open to participants now.
SCARM Institute, Tabriz, Iran has 2 studies filed under Heart Failure — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 10 studies in Heart Failure with a site in Iran, Islamic Republic of, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
This is a prospective, randomised double blind, controlled, parallel-group phase I and II study. Its aim is to assess the Evaluation of the intramyocardial injection of autologous bone marrow derived mononuclear stem cells is safe and effective in hear failure patients with reduced left ventricular ejection fraction(\<=30%) when compared to a control group of patients undergoing best medical care.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Intramyocardial injection of autologous bone marrow mononuclear cells in patients with Heart Failure
Biological: Intramyocardial injection of stem cell
Placebo intramyocardial injection in patients with Heart Failure
Biological: Placebo
Autologous bone marrow-derived mononuclear cells are obtained from 100-150ml of bone marrow aspirated under local anaesthesia from the iliac crest. Intramyocardial injection of the cells is performed in patients with Heart failure in open heart surgery (CABG)
Injection of Placebo in patients with Heart failure in open heart surgery (CABG)
Death
The rate of patients mortality after transplantation
Time frame: 12 months
Hospitalization
the rate of hospitalization after transplantation
Time frame: 12 months
Ejection fraction changes
Elevation of ejection fraction in patients after transplantation
Time frame: 12 months
6-minute walk test (6MWT)
Evaluation the improvement of 6MWT test after transplantation
Time frame: 12 months
Pro b-type natriuretic peptide (Pro-BNP) changes
Elevation the reduction of Pro-BNP in patients after transplantation
Time frame: 12 months
NYHA functional class
Evaluation the improvement of NYHA functional class in patients
Time frame: 12 months
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Oct 2020; primary completion for Aug 2021, 9 months later.
Of 43 phase 1/2 interventional studies under Heart Failure, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 48. This study's planned 9 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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SCARM Institute, Tabriz, Iran