RECRUITING

Evaluation of Umbilical Cord-Derived Wharton's Jelly Stem Cells for the Treatment of Acute Graft Versus Host Disease

Conditions

Acute Graft Versus Host Disease mesenchymal stem cell hematopoietic stem cell transplant Allogeneic hematopoietic stem cell transplant Autologous hematopoietic stem cell transplant Wharton's jelly umbilical cord blood steroid refractory graft versus host disease

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study evaluates the safety and effectiveness of two different doses of umbilical cord derived, ex-vivo cultured and expanded Wharton's jelly mesenchymal stem cells (MSCTC-0010) in the treatment of acute Graft versus Host Disease (aGVHD). The first 5 participants enrolled in the study will receive a lower dose of MSCTC-0010. If none of the first 5 participants have treatment-related serious adverse events (TRSAEs) for 42 days, then the next 5 participants will receive a slightly higher dose of MSCTC-0010.

Official Title

A Phase I Study To Evaluate the Safety of Umbilical Cord - Derived, Ex-Vivo Cultured and Expanded Wharton's Jelly Mesenchymal Stem Cells for the Treatment of De Novo High Risk Acute or Steroid Refractory Acute Graft Versus Host Disease

Quick Facts

Study Start:2018-07-09

Study Completion:2025-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03158896

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Age: ≥ 18 years of age and ≤ 75 years of age. * Women of child-bearing potential and men with partners of child-bearing potential must agree to practice sexual abstinence, or to use two forms of adequate contraception (hormonal AND barrier method of birth control) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. If a woman becomes pregnant or suspects she is pregnant while participating in this study, she should inform her treating physician immediately. * A woman of child-bearing potential is any female (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: * Has not undergone a hysterectomy or bilateral oophorectomy; OR * Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months) * Men of child-bearing potential must not donate sperm while on this study and for 90 days after their last study treatment. * NOTE: Acceptable forms of birth control are listed below: * One Barrier method (cervical cap with spermicide plus male condom; diaphragm with spermicide plus male condom) PLUS * Hormonal method (oral contraceptives, implants, or injections) or an intrauterine device (e.g., Copper-T). * Participant must have de novo HR or steroid refractory, Grade II-IV aGVHD as defined in Appendix 1. NOTE: Biopsy at screening only for evaluation of aGVHD is not mandatory, but is recommended when feasible. Enrollment should not be delayed awaiting biopsy results. * Participant must have received an allogenic transplant at Kansas University Cancer Center/University of Kansas Medical Center (KUCC / KUMC).	* Participants may not have received any other investigational agent used to treat acute GVHD for 30 days prior to enrollment. * Participant has any underlying or current medical or psychiatric condition that, in the opinion of the Investigator, would interfere with the evaluation of the participant.

Inclusion Criteria

Exclusion Criteria

* Age: ≥ 18 years of age and ≤ 75 years of age.
* Women of child-bearing potential and men with partners of child-bearing potential must agree to practice sexual abstinence, or to use two forms of adequate contraception (hormonal AND barrier method of birth control) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. If a woman becomes pregnant or suspects she is pregnant while participating in this study, she should inform her treating physician immediately.
* A woman of child-bearing potential is any female (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
* Has not undergone a hysterectomy or bilateral oophorectomy; OR
* Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)
* Men of child-bearing potential must not donate sperm while on this study and for 90 days after their last study treatment.
* NOTE: Acceptable forms of birth control are listed below:
* One Barrier method (cervical cap with spermicide plus male condom; diaphragm with spermicide plus male condom) PLUS
* Hormonal method (oral contraceptives, implants, or injections) or an intrauterine device (e.g., Copper-T).
* Participant must have de novo HR or steroid refractory, Grade II-IV aGVHD as defined in Appendix 1. NOTE: Biopsy at screening only for evaluation of aGVHD is not mandatory, but is recommended when feasible. Enrollment should not be delayed awaiting biopsy results.
* Participant must have received an allogenic transplant at Kansas University Cancer Center/University of Kansas Medical Center (KUCC / KUMC).

* Participants may not have received any other investigational agent used to treat acute GVHD for 30 days prior to enrollment.
* Participant has any underlying or current medical or psychiatric condition that, in the opinion of the Investigator, would interfere with the evaluation of the participant.

Contacts and Locations

Study Contact

Kerry Hepler

CONTACT

913-945-7552

khepler@kumc.edu

Principal Investigator

Joseph McGuirk, DO

PRINCIPAL_INVESTIGATOR

The University of Kansas - Cancer Center

Study Locations (Sites)

Kansas University Cancer Center

Kansas City, Kansas, 66160

United States

Collaborators and Investigators

Sponsor: University of Kansas Medical Center

Joseph McGuirk, DO, PRINCIPAL_INVESTIGATOR, The University of Kansas - Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-07-09

Study Completion Date2025-08

Study Record Updates

Study Start Date2018-07-09

Study Completion Date2025-08

Terms related to this study

Keywords Provided by Researchers

mesenchymal stem cell
hematopoietic stem cell transplant
Allogeneic hematopoietic stem cell transplant
Autologous hematopoietic stem cell transplant
Wharton's jelly
umbilical cord blood
steroid refractory graft versus host disease

Additional Relevant MeSH Terms

Acute Graft Versus Host Disease