An Early Phase 1 interventional study of mesenchymal stem cell infusion and bone marrow mononuclear cell infusion in Osteochondritis of the Femoral Head, sponsored by Jianming Tan. Status unknown at 1 site in China. Open to participants aged 12 Years to 60 Years. Per ClinicalTrials.gov, last updated 2012-10-10.
Sponsored by Jianming Tan · Early Phase 1, Interventional, and Treatment
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Mesenchymal Stem Cells (MSCs) have been shown to have immunosuppressive and repairing properties. Bone marrow mononuclear cells (BMMNCs) have revascularization properties and complimentary effects to MSCs. The investigators will infuse expanded autologous MSCs and BMMNCs into patients with osteonecrosis of the femoral head. The study purpose is to examine whether this treatment will result in improvement in osteonecrosis of the femoral head.
Mesenchymal Stem Cells (MSCs) have been shown to have immunosuppressive and repairing properties. Bone marrow mononuclear cells (BMMNCs) have revascularization properties and complimentary effects to MSCs. Patients in this study will receive infusion of expanded autologous MSC and BMMNCs. The puncture of femoral artery will be conducted with digital subtraction angiography(DSA), and the tubes will be inserted into medial femoral circumflex artery,lateral femoral circumflex artery and obturatou artey. The study will evaluate the safety and effectiveness of MSC infusion in patients with osteonecrosis of the femoral head. This study will last for 5 years. Patients will undergo infusions at Day 0. Afterward, patients will be evaluated for response, and undergo X-ray examination, CT and MR scanning at a 6-month interval.
25 studies on the registry are indexed under Legg-Calve-Perthes Disease; 7 are open to participants now.
This study's enrollment of 15 is below the median of 30 across 15 interventional studies indexed under Legg-Calve-Perthes Disease.
Browse Legg-Calve-Perthes Disease studies →This is the only study on the registry with Jianming Tan as lead sponsor.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
mesenchymal stem cell infusion and bone marrow mononuclear cell infusion
Biological: mesenchymal stem cell infusion · Biological: bone marrow mononuclear cell infusion
Also known as: MSC infusion
Also known as: BMMNC infusion
The femoral head blood-supply artery angiographies and the areas of femoral head necrosis
Time frame: 2
Coxa joint paining
Time frame: 2
Walking distance
Time frame: 2
Joint functions
Time frame: 2
Life
Time frame: 2
The record gives a start of Dec 2009, a primary completion of Aug 2011 and a completion of Aug 2015. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Oct 2012. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Mesenchymal Stem Cell