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Allogenic Bone Marrow Mesenchymal Stem Cells Infusion in Patients With Steroid-refractory GVHD

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ClinicalTrials.gov Identifier: NCT02824653
Recruitment Status : Completed
First Posted : July 7, 2016
Last Update Posted : January 25, 2017
Sponsor:
Information provided by (Responsible Party):
Armed Forces Bone Marrow Transplant Center, Rawalpindi, Pakistan

Brief Summary:
Graft versus host disease is a serious and often life-threatening complication in allogeneic haematopoietic stem cell transplantation. Although corticosteroids are the first-choice of treatment in these patients, but about 30-50% patients do not respond to it and develop steroid-refractory GVHD. Mesenchymal stem cells (MSC) have emerged as a promising treatment option in these patients. This phase-I/II clinical trial aims at establishing the safety and clinical efficacy of allogenic ex-vivo cultured MSCs to treat steroid-refractory GVHD in a Pakistani HSCT cohort.

Condition or disease Intervention/treatment Phase
Graft Versus Host Disease Biological: Mesenchymal Stem Cells Phase 1 Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Allogenic Bone Marrow Mesenchymal Stem Cells Infusion in Patients With Steroid-refractory GVHD- A Phase I/II Clinical Trial
Study Start Date : January 2015
Actual Primary Completion Date : July 2016
Actual Study Completion Date : December 2016


Arm Intervention/treatment
Experimental: Mesenchymal Stem Cells
The experimental arm is comprised of GVHD patients receiving allogenic bone marrow mesenchymal stem cells
Biological: Mesenchymal Stem Cells
Allogenic Human Bone Marrow Mesenchymal Stem Cells (ex-vivo expanded in pooled human platelet lysate)
Other Name: Allogenic Bone Marrow MSCs




Primary Outcome Measures :
  1. Incidence of treatment-emergent adverse events and complications [Safety and Tolerability] [ Time Frame: 4 weeks ]
    Safety will be evaluated by reporting any incidence of adverse event, complication and toxicity related to administration of MSCs within 4 weeks of last infusion .

  2. Acute GVHD-restaging [Efficacy] [ Time Frame: 4 weeks ]
    Efficacy of ex-vivo expanded allogenic mesenchymal stem cell infusion will be determined by organ-specific re-staging and global grading of Acute GVHD as per consensus group criteria. Response will be measured as complete response (CR), partial response (PR), stable disease(SD) and progressive disease(PD). CR:acute GVHD symptoms and signs disappear; PR:aGVHD symptoms and signs improve; SD:aGVHD symptoms and signs remain (without improvement or deterioration);PD: aGVHD symptoms and signs deteriorate.

  3. Chronic GVHD-restaging [Efficacy] [ Time Frame: 3 months ]
    Organ-specific scoring and global scoring of chronic GVHD will be done as per NIH consensus criteria of 2014. Treatment response will be measured as complete response (CR), partial response (PR), stable disease(SD) and progressive disease(PD). CR:chronic GVHD symptoms and signs disappear; PR:cGVHD symptoms and signs improve; SD:cGVHD symptoms and signs remain (without improvement or deterioration);PD: cGVHD symptoms and signs deteriorate.


Secondary Outcome Measures :
  1. Survival analysis at six months after MSC infusion [ Time Frame: 6 months ]

    Documenting patients' survival status after 6 months of receiving MSC infusion

    To document relapse of hematological malignancies post-MSC infusion.

    Evaluation of late infectious complications or toxicities after MSC infusion.


  2. Incidence free survival at six months after MSC infusion [ Time Frame: 6 months ]
    To document rate of GVHD recurrence in patients after MSC infusion.



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Ages Eligible for Study:   1 Year to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must fill Informed consent.
  • Patient who has undergone allogeneic HSCT and has steroid-refractory grade II-IV acute GVHD.
  • Patients who did not respond to treatment options including methylprednisolone, and or cyclosporine A or ATG.
  • Patients who despite above mentioned treatment have unresponsive GVHD after 5 days or progressive acute GVHD for more than 72 hours.
  • Patients who have received any other treatment and had discontinued for non-responsiveness.

Exclusion Criteria:

  • Poor performance status, not expected to survive 5 days.
  • Patients with hypersensitivity to penicillin and/or gentamycin.
  • Poor compliance.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02824653


Locations
Pakistan
Armed Forces Bone Marrow Transplant Centre
Rawalpindi, Punjab, Pakistan, 46000
Sponsors and Collaborators
Armed Forces Bone Marrow Transplant Center, Rawalpindi, Pakistan
Investigators
Principal Investigator: Parvez Ahmed, FCPS, MCPS Armed Forces Bone Marrow Transplant Centre, Rawalpindi, Pakistan

Responsible Party: Armed Forces Bone Marrow Transplant Center, Rawalpindi, Pakistan
ClinicalTrials.gov Identifier: NCT02824653     History of Changes
Other Study ID Numbers: AFBMTC-GVHD-2015
First Posted: July 7, 2016    Key Record Dates
Last Update Posted: January 25, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Armed Forces Bone Marrow Transplant Center, Rawalpindi, Pakistan:
acute GVHD
chronic GVHD
steroid-refractory
Mesenchymal Stem Cells

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases