An interventional study of Intravenous infusion of cord blood mononuclear cells and application of granulocyte stimulating factor in Cord, sponsored by Qianfoshan Hospital. Status unknown at 1 site in China. Open to participants aged 1 Year to 17 Years. Per ClinicalTrials.gov, last updated 2022-11-28.
Sponsored by Qianfoshan Hospital · Not applicable, Interventional, and Treatment
This project aims to investigate the therapeutic and repair effects of cord blood mononuclear cells (MNCs) on bone marrow failure after chemotherapy in children with malignant diseases. It is planned to collect 20 malignant children with bone marrow failure after chemotherapy and randomly divide them into two groups. The umbilical cord blood mononuclear cells were injected, ≥1×10\^8 per infusion, once a week, and the recovery time of peripheral blood leukocytes, neutrophils, platelets and hemoglobin was observed. According to the recovery of myelosuppression, stop when the peripheral blood reaches leukocytes>1×10\^9/L, neutrophils>0.5×10\^9/L, platelets>25×10\^9/L, and hemoglobin>60g/L at the same time. Use, share 1-4 times.
Statistical software was used to compare the changes of peripheral blood leukocytes, neutrophils, platelets and hemoglobin before the start of the test (0d) and 1d, 3d, 5d, 7d, 10d, and 14d after the start of the test, as well as the severity of concurrent infections and antibiotic use Time, number of infusions of blood products.
The standard of bone marrow failure after chemotherapy is based on theWorld Health Organization(WHO) grade IV myelosuppression standard, that is, peripheral blood white blood cells (WBC) \< 1 × 10\^9/L, neutrophils (N) \<0.5 × 10\^9/L, platelets (PLT) \<25×10\^9/L, hemoglobin (Hb) \<60g/L, for more than 2 weeks. It is planned to collect 20 malignant children with bone marrow failure after chemotherapy and randomly divide them into two groups. The umbilical cord blood mononuclear cells were injected, ≥1×10\^8 per infusion, once a week, and the recovery time of peripheral blood leukocytes, neutrophils, platelets and hemoglobin was observed. According to the recovery of myelosuppression, when the peripheral blood reaches WBC>1×10\^9/L, N>0.5×10\^9/L, PLT>25×10\^9/L, and Hb>60g/L at the same time, it should be discontinued and used together. 1-4 times.
Safety evaluation: Children under treatment who meet any one or more of the following, the study will be terminated or withdrawn: (1) Within 6 hours after the treatment with venous cord blood mononuclear cells, the clinical symptoms that cannot be explained by known causes are significantly aggravated or In case of deterioration, the trial should be terminated, and appropriate treatment should be carried out. The withdrawn cases should be included in the clinical efficacy evaluation, and the count is invalid; (2) During the treatment and within 6 hours after the treatment, the following conditions that cannot be explained by the known causes occur: severe hypotension, contraction Blood pressure drops ≥20mmHg or systolic blood pressure \<70mmHg; severe hypertension, systolic blood pressure rises ≥20mmHg or systolic blood pressure>140mmHg, the test should be terminated; (3) During treatment and within 6 hours after treatment, chills, Patients with fever (body temperature ≥39°C), rash, headache, low back pain and other symptoms should stop the test; (4) If serious adverse events occur, the test should be stopped.
Efficacy evaluation: compare the changes of peripheral blood leukocytes, neutrophils, platelets and hemoglobin before the start of the test (0d) and 1d, 3d, 5d, 7d, 10d, and 14d after the start of the test, as well as the severity of concurrent infection and antibiotic use Time, number of infusions of blood products.
39 studies on the registry are indexed under Cone-Rod Dystrophies; 14 are open to participants now.
This study's planned enrollment of 20 is below the median of 28 across 28 interventional studies indexed under Cone-Rod Dystrophies.
Browse Cone-Rod Dystrophies studies →Qianfoshan Hospital is the lead sponsor of 144 studies on the registry; 75 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
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.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
granulocyte stimulating factor(5ug/kg/d) +infusion of umbilical cord blood mononuclear cells, each infusion ≥1×10\^8, once a week
Other: Intravenous infusion of cord blood mononuclear cells · Drug: application of granulocyte stimulating factor
granulocyte stimulating factor 5ug/kg/d
Drug: application of granulocyte stimulating factor
On the basis of the application of granulocyte stimulating factor, the research group was given intravenous infusion of umbilical cord blood mononuclear cells, each infusion ≥1×10\^8, once a week
application of granulocyte stimulating factor
recovery time of peripheral neutrophils
Observe the recovery time of peripheral neutrophils
Time frame: 20days
frequency of infection
frequency of infection
Time frame: 20days
Plan to share: No — To be published in an appropriate form at the complete conclusion of the study
No publications or documents are linked to this record.
Started Oct 2022 (actual). Primary completion is estimated for Sep 2024, 23 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.