Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Infections

Symptoms and General Pathology

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Thrombocytopenia

Lymphoma

Leukemia

Hemorrhage

Hematologic Neoplasms

Communicable Diseases

Anemia

Neutropenia

Hematologic Diseases

Blood Platelet Disorders

Cytopenia

Agranulocytosis

Leukopenia

Leukocyte Disorders

Lymphosarcoma

Granulocytopenia

In the Phase Ib study, participants will be those with treatment-induced myelosuppression and acute myeloid leukemia/acute lymphoblastic leukemia, UC-MSCs will be preset with 5 escalation dose levels: dose A , dose B, dose C ,dose D and dose E, frequency of infusion will be preset with 3 escalation levels: frequency 1, frequency 2, frequency 3, total course of treatment: 2 weeks; In the Phase II study, participants will be those with treatment-induced myelosuppression and acute myeloid leukemia/acute lymphoblastic leukemia/primary hematological maligancies who are going to receive hematopoietic stem cell transplantation, UC-MSCs will be preset according to the recommended phase II dose (RP2D) from the Phase Ib study, total course of treatment: 2 weeks.

umbilical cord derived mesenchymal stem cells, intravenous infusion

umbilical cord derived mesenchymal stem cells

Qiubai Li, Professor

Hongxiang Wang, Professor

Yicheng Zhang, Professor

The purpose of the study is to explore the safety and efficacy of umbilical cord derived mesenchymal stem cells in treatment-induced myelosuppression in patients with hematologic malignancies.

Despite the improved prognosis of patients with hematologic malignancies, almost all patients will experience severe myelosuppression induced by anti-cancer treatment, leading to a series of complications such as infection due to neutropenia, bleeding due to thrombocytopenia and/or impaired major organ function such as cardiac function due to anemia, which are the main reasons for dose reduction, dose interrruptions of anti-cancer treatment, failure of hematopoietic stem cell transplantation, and also patients' treatment-related death. It is of significant clinical importance and an urgent need to promote early recovery of myelosuppression and reduce risks of related complications as well as medical burdens. Umbilical cord derived mesenchymal stem cells (UC-MSCs), as a kind of stem cells with multipotential, can widely act on the functional cell units of bone marrow microenvironment and promote the repairment and regeneration of key cells such as hematopoietic stem cells, mesenchymal stem cells and endothelial cells, thus making it an ideal means for effectively promoting recovery of myelosuppression. Patients with hematologic malignancies and treatment-induced myelosuppression will be invited to participate in the Phase Ib/II study, to receive UC-MSCs intravenous infusion and follow-up visits of up to 2 years after enrollment.

Umbilical Cord Derived Mesenchymal Stem Cells for Treatment-induced Myelosuppression in Hematologic Malignancies

A Multicenter, Phase Ib/II Trial of the Safety and Efficacy of Umbilical Cord Derived Mesenchymal Stem Cells in Treatment-induced Myelosuppression in Patients With Hematologic Malignancies (USMYE Trial)

During the DLT observation period, the subject has an adverse event that is reasonably related to UC-MSCs infusion (possibly, likely or definitely related).

To investigate the safety characteristics, percentages will be calculated and grade will be evaluated.

During the dose-escalation phase, the highest dose of dose-limiting toxicity for subjects less than or equal to 1/3 in the dose group of at least 6 evaluble subjects of the study drug after the last UC-MSCs dose.

To investigate the efficacy characteristics, time will be measured in days.

To investigate the efficacy characteristics, percentages will be calculated.

To investigate the efficacy characteristics, the duration will be measured in days.

To investigate the safety characteristics, the duration will be measured in days or months.

From enrollment to the day of death caused by any reason.

To investigate the safety characteristics, percentages will be calculated.

Wuhan TongJi Hospital

Wuhan Central Hospital

Wuhan Union Hospital, China

M.D. & Ph.D., Professor

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Syndrome

Polycystic Ovary Syndrome

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Gonadal Disorders

Endocrine System Diseases

Cultured allogeneic adult umbilical cord derived mesenchymal stem cells

AlloRx

Chadwick C Prodromos, MD

This trial will study the safety and efficacy of cultured allogeneic adult umbilical cord derived mesenchymal stem cells delivered intravenously for the treatment of Polycystic Ovary Syndrome.

Stem cell treatment has shown efficacy for PCOS in both human and animal studies. We are also reporting completer resolution of polycystic ovary syndrome (PCOS) in a young woman after a single intravenous injection of umbilical cord derived mesenchymal stem cells (UCDSC). We hypothesized that intravenous infusion of UCDSC can reduce or eliminate PCOS. Patients will receive roughly 2 million umbilical cord derived mesenchymal stem cells per kg of body weight. Hormone levels and ultrasound will be checked 3,6 and 12 months after treatment.

Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for PCOS

Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for the Treatment of Polycystic Ovary Syndrome

Clinical monitoring of possible adverse events or complications

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Umbilical Cord Derived Mesenchymal Stem Cells for Treatment-induced Myelosuppression in Hematologic Malignancies	NCT05672420	Hematologic Neo... Neutropenia Anemia Thrombocytopeni... Infections Bleeding	umbilical cord ...	18 Years - 75 Years	Wuhan Union Hospital, China
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for PCOS	NCT06143527	Polycystic Ovar... Polycystic Ovar... PCOS	AlloRx	18 Years -	The Foundation for Orthopaedics and Regenerative Medicine
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for PCOS	NCT06143527	Polycystic Ovar... Polycystic Ovar... PCOS	AlloRx	18 Years -	The Foundation for Orthopaedics and Regenerative Medicine

Spots Global Cancer Trial Database for umbilical cord derived mesenchymal stem cells