Using autologous blood transfusion with stem cells to protect bone marrow in cervical cancer patients

Stored Hematopoietic Stem Cell-containing Autologous Blood Transfusion Therapy for Bone Marrow Protection in Patients With Cervical Cancer Treated With Concurrent Chemoradiotherapy

This study is testing if giving cervical cancer patients their own blood with stem cells after treatment can help them recover their blood cell production faster and better than standard care.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 60 Years
• Sex: Female
• Sponsor: Chongqing University Cancer Hospital (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Chongqing, Chongqing Municipality)
• Trial ID: NCT05401175 on ClinicalTrials.gov

What this trial studies

This project aims to enhance the recovery of hematopoietic function following chemoradiotherapy in cervical cancer patients through the innovative use of autologous blood transfusions containing hematopoietic stem cells. In a prospective, single-center, non-randomized controlled design, patients will be divided into two groups: one receiving the stem cell transfusion after treatment and the other receiving standard care. The study will monitor the incidence and duration of severe neutropenia and the time taken for hematopoietic recovery, alongside evaluating safety and other secondary endpoints related to treatment delays and adverse events.

Who should consider this trial

Good fit: Ideal candidates are pre-menopausal women aged 18-60 with a confirmed diagnosis of cervical cancer who are eligible for concurrent chemoradiotherapy.

Not a fit: Patients with existing bone marrow diseases or those with metastases to the central nervous system or bone marrow are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve bone marrow recovery and overall treatment outcomes for cervical cancer patients undergoing chemoradiotherapy.

How similar studies have performed: While the use of stem cell support in cancer treatment is established, the specific application of autologous blood transfusion for bone marrow protection in cervical cancer is relatively novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

1）18-60 years old; 2)there are radiotherapy and chemotherapy indicators for cervical cancer;3)pathological diagnosis of squamous, adenocarcinoma or adenosquamous carcinoma;4)the Eastern Cooperative Oncology Group (ECOG) performance status score≤1; 5)the expected survival time was more than 3 months; 6)pre-menopausal women (post-menopausal women must have been postmenopausal for at least 12 months to be considered infertile), and the serum pregnancy test results are negative;7)all patients must agree to take effective contraceptive measures during the study period and within 6 months after stopping treatment;8)the subjects voluntarily participate in this clinical trial sign an informed consent form and are able to complete the study procedures and follow-up examinations.

Exclusion Criteria:

1\) clinical diagnosis of bone marrow disease;2) imaging or pathological diagnosis of central nervous system or soft meningeal or bone or bone marrow metastases;3)patient has severe cardiac insufficiency;4)previous history of allogeneic stem cell transplantation or organ transplantation;5)patients with active bleeding and autoimmune thrombocytopenic purpura;6)patients with radiochemotherapy contraindications;7)positive for human immunodeficiency virus (HIV);8)acute or chronic active hepatitis B or hepatitis C infection;9)History of gastrointestinal perforation and/or fistula, clinical signs or symptoms of intestinal obstruction and/or gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), inflammatory bowel disease or extensive bowel resection (partial colectomy or extensive small bowel resection complicated by chronic diarrhoea), Crohn's disease, ulcerative colitis or chronic diarrhoea within the previous 6 months;10)evidence of an intra-abdominal pneumoperitoneum that cannot be explained by puncture or recent surgical intervention.

Where this trial is running

Chongqing, Chongqing Municipality

• Chongqing University Cancer Hospital — Chongqing, Chongqing Municipality, China (RECRUITING)

Study contacts

• Principal investigator: Dongling Zou, M.D. — Chongqing University Cancer Hospital
• Study coordinator: Dongling Zou, M.D.

Conditions: Cervical Cancer, concurrent chemoradiotherapy, blood stem cells, autologous blood transfusion