Using stem cells from umbilical cords to treat acute Graft Versus Host Disease
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
This study is testing if using stem cells from umbilical cords can help treat acute Graft Versus Host Disease in patients who don't respond well to regular steroid treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | University of Kansas Medical Center Academic / other |
| Locations | 1 site (Kansas City, Kansas) |
| Trial ID | NCT03158896 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effectiveness of two different doses of umbilical cord-derived Wharton's jelly mesenchymal stem cells (MSCTC-0010) for treating acute Graft Versus Host Disease (aGVHD). The first five participants will receive a lower dose, and if they experience no serious adverse events, the next five will receive a higher dose. The goal is to find a viable alternative to standard steroid-based therapies, especially for patients who are resistant to such treatments. The study aims to address the urgent need for effective therapies in patients with high-risk or steroid-refractory aGVHD.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 who are experiencing acute Graft Versus Host Disease.
Not a fit: Patients who are not experiencing acute Graft Versus Host Disease or those outside the age range of 18 to 75 may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new, effective option for patients suffering from acute Graft Versus Host Disease.
How similar studies have performed: Other studies have shown promise in using mesenchymal stem cells for similar conditions, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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).
Exclusion Criteria:
* 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.
Where this trial is running
Kansas City, Kansas
- Kansas University Cancer Center — Kansas City, Kansas, United States (Recruiting)
Study contacts
- Principal investigator: Joseph McGuirk, DO — The University of Kansas - Cancer Center
- Study coordinator: Kerry Hepler
- Email: khepler@kumc.edu
- Phone: 913-945-7552
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.