Cell Therapy for Intestinal Transplantation

Phase-Based Estimates
1
Effectiveness
1
Safety
Columbia University Irving Medical Center/NYP, New York, NY
Cell Therapy - Biological
Eligibility
18+
All Sexes
Eligible conditions
Intestinal Transplantation

Study Summary

This study is evaluating whether bone marrow cells from the same donor of the transplanted organ(s) could promote a state called "mixed chimerism" in which both donor cells and

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Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Cell Therapy will improve 1 primary outcome and 2 secondary outcomes in patients with Intestinal Transplantation. Measurement will happen over the course of Up to 4 years after transplantation.

Year 3
Graft survival rate
Retention rate
Year 4
Total number of participants with moderate to severe GVHD

Trial Safety

Trial Design

2 Treatment Groups

Control
Cell Therapy

This trial requires 6 total participants across 2 different treatment groups

This trial involves 2 different treatments. Cell Therapy is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Cell Therapy
Biological
Patients will receive an infusion containing 1x106/kg CD34+ cells. No more than 104 CD34+ T cells per kg recipient weight will be included in the infusion. Cadaveric donor CD34 cell infusion will occur at any time between post-operative day 11 to day 13 following transplantation.
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cell Therapy
2006
Completed Phase 3
~150

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 3 years after transplantation
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 3 years after transplantation for reporting.

Closest Location

Columbia University Irving Medical Center/NYP - New York, NY

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
and Constipation Chronic intestinal pseudo-obstruction is a rare, devastating disorder characterized by a slow, progressive loss of intestinal motility show original
Microvillus inclusion disease is a rare disorder that affects the intestinal lining show original
Tufting Enteropathy
Crohn's Disease
Hirschprung's Disease
Trauma (multiple resections/explorations and/or vascular abdominal trauma superior mesenteric artery (SMA) / superior mesenteric vein (SMV) injuries)
Gastroschisis
Volvulus
Necrotizing Enterocolitis
Intestinal atresia is a problem that affects the intestines show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the signs of intestinal transplantation?

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The course of disease can be divided into three phases after transplantation and in many ways resemble that of inflammatory bowel disease. The first phase involves only mild gastrointestinal symptoms which resolve spontaneously within a year or two. The second phase of chronic gastrointestinal problems occurs in about 65% of patients, usually due to immunosuppressive medication. Patients on cyclosporine, azathioprine or tacrolimus are more likely to have chronic gastrointestinal symptoms and may progress to severe long-term problems. Patients who have a HLA-DQ1 mismatch are at an increased risk of developing chronic gastrointestinal symptoms.

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How many people get intestinal transplantation a year in the United States?

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About 10,000 people must undergo a transplant to be diagnosed with an intestinal disease in the United States each year. About 14,000 people undergo a transplant operation.

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What is intestinal transplantation?

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Enteral nutrition in intestinal transplant recipients, especially with immunosuppressive drug therapy, has been associated with an increased rate of infectious complications such as bacteremia, osteomyelitis, graft-versus-host disease, and systemic infections. We conclude that more careful, personalized nursing and careful monitoring is necessary during the post transplant intensive care unit phase. For this reason, we have introduced a nursing practice guideline for intestinal transplantation patients. The principles and guidelines described, in addition to existing recommendations for optimal nutrition and nursing care, can be used by other gastrointestinal transplant units to develop strategies to implement similar guidelines.

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What are common treatments for intestinal transplantation?

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There are differences in the use of medications depending on transplant center and on transplant organ(s) obtained. The types and numbers of medications used to prevent or treat complications vary widely depending on the type of transplant and organ transplanted, with many centers using multiple medications. Many people receiving an organ transplant use more medications than general populations.

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Can intestinal transplantation be cured?

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Intestinal graft failure has a substantial morbidity and mortality. For the patient with intestinal failure, a successful intestinal transplantation remains unlikely if recovery of the graft fails. Transplantation of grafts from patients with long-term graft survival should be considered.

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What causes intestinal transplantation?

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This experience suggests that the mechanism whereby intestinal transplantation produces clinical outcomes is not dependent upon either a donor or recipient of a T-cell dependent immune response to a non-cross-reacting antigens. In a recent study, findings have clarified the mechanism of graft acceptance and its regulation in transplantation into an immunocompetent recipient, with the result that graft acceptance is not dependent on either a T-cell response to donor or recipient antigens or their cross-reactivity.

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Have there been any new discoveries for treating intestinal transplantation?

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No new evidence has been identified that would make routine immunosuppression mandatory for all patients undergoing intestinal [transplant](https://www.withpower.com/clinical-trials/transplant)ation. In fact, the current data indicate that immunosuppression is often ineffective and in fact can cause serious transplantation complications. Moreover, the risk of graft loss after 2 years of treatment is around 40%, which is higher than the rate for patients with chronic obstructive pulmonary disease (10%) and very high risk (20-50% overall) for lung transplantation with the use of an HLA-matched compatible donor.

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What is the primary cause of intestinal transplantation?

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Most cases of primary intestinal transplantation can be attributed to the following categories of circumstances: non-human immunodeficiency virus-infected individuals, recipients of deceased donor transplants, and individuals who suffer a massive and devastating complication resulting from severe immune deficiency. The overall incidence of primary transplantation in the United States is approximately 0.07-0.14/100,000/year. It is a significant problem in our country, and research evaluating the incidence of secondary intestinal transplantation is needed.

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What are the common side effects of cell therapy?

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In a recent study, findings, patients received an average of four treatments, while most were transplanted with the patient's own cells. The average time from injection to the patient's next treatment was about 26 weeks. We observed common complaints such as: nausea, vomiting, fatigue or pain. We suspect that these findings may be related to the patients' psychological anxiety and distress before the procedure, the side effects from the infusion, the immunosuppressive therapy, or the cell therapy itself, and we suggest that the patient's psychological state is very important to the safety and efficacy of cell-therapy protocols.

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What are the latest developments in cell therapy for therapeutic use?

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Currently, cell therapy is usually only used for the treatment of diseases where no effective pharmaceutical treatment alternative exists. However, despite the many limitations of cell therapy, it is conceivable that the therapeutic potential of stem cells will be exploited in the future for patients with various cancers, especially after the results of clinical trials have been reported. However, we need to know whether the long and sometimes unpredictable development of effective antitumor immunological responses is due to a failure of current treatments or to the limited therapeutic possibilities of cell therapies.

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What is the average age someone gets intestinal transplantation?

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In the USA, the mean age a child receives a small bowel transplant is 8.1 years. This is consistent with other international reports of young children receiving small intestinal transplantation. Further research, in part funded by the NIH, is warranted to assess why children with an HLA mismatch are transplanted at a somewhat older age, and may be a matter of age, transplant center, or hospital protocol. (Izady R, et al. Pediatr Hosp Clin N Am 2007;16:13-18).

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How does cell therapy work?

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This report is a case report of the effect of cell therapy with mesenchymal stem cells and MSCs on liver regeneration. The authors reported the first recovery of liver function after more than 12 months when they used MSCs alone or combined with mesenchymal stem cells. They were able to treat eight transplant patients with allogenic and autologous grafts.

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