Ignite Creation Date:
2024-07-17 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06499246
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-07-06
Brief Title:
Parathyroid Allotransplant for Severe Refractory Hypoparathyroidism
Sponsor:
Karen Devon
Organization:
University Health Network Toronto
Study Overview
Official Title:
Parathyroid Allotransplant for Severe Refractory Hypoparathyroidism
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Hypoparathyroidism following thyroid surgery presents significant challenges often leading to debilitating symptoms and reduced quality of life despite conventional treatment Having now reported the first successful case of a deceased donor fresh tissue parathyroid allotransplant with immunosuppression in a transplant-naive recipient the purpose of this study is to further assess the safety and efficacy of this procedure in patients with severe intractable post-surgical hypoparathyroidism
Detailed Description:
A protocol for deceased donor parathyroid transplantation was developed with the University Health Network Ajmera Transplant Centre in Toronto relevant stakeholders and presented to the innovation committee and REB for approval Health Canada approval was obtained under the scope of existing cell tissue and organ regulations within the provincial organ procurement agency
This is a pilot prospective case-series It includes a cohort of patients with hypoparathyroidism who will undergo parathyroid transplantation from a neurologically deceased donor There is no control group in this study
Patients with permanent refractory hypoparathyroidism after total thyroidectomy will be entered in this study to undergo parathyroid transplantation from a neurologically deceased donor Inclusion criteria are patients who have had a prior total thyroidectomy with both biochemical hypoparathyroidism and symptomatic hypocalcemia numbness tingling or other neurologic symptoms requiring daily high dose calcium greater than 2000 mg per day vitamin D greater than 2 mcg of calcitriol per day supplementation andor intermittent IV calcium infusion Patients for inclusion must have failed this medical management after at least 1 year of treatment and meet standard criteria for receiving organ transplant
All patients will have at least one pre-operative clinic visit with the endocrine surgery endocrinology and transplant team for comprehensive assessment Baseline blood work will be conducted at this pre-operative visit as outlined in the study protocol The patient will also be evaluated by psychiatry and complete any necessary age appropriate comprehensive cancer screening as per standard transplantation protocol Completeness of pre-transplant vaccinations pneumococcus HBV influenza Tdap HAV will be reviewed and arranged in co-ordination with patients primary care provider as necessary If based on pre-transplant work up a participant is deemed to meet exclusion criteria and not be suitable for transplant this will be discussed with the participant and they will be withdrawn from the study Participants will be informed of the need to fulfill the previously listed standard transplant criteria during the informed consent process
Once a potential donor becomes available the transplant team will decide whether the donor is a match for a study participant A rigorous protocol for donor selection and transplantation was developed Donor criteria aimed at minimizing infectious and immunological risks HLA matching A history of hyperparathyroidism primary secondary or tertiary will also be screened for in the donor as the presence of hyperparathyroidism would be an exclusion criteria to procure their parathyroid glands for this study If the donor is a match for a study participant the participant will be contacted and timing of retrieval and patient arrival at TGH will be coordinated The procurement team will then with appropriate timing procure all parathyroid tissue using standard surgical techniques and the tissue will be kept in organ preservation solution in a sterile specimen cup with a cold ischemic time of less than 2 hours
The study participant will be admitted to the hospital under the Multi Organ Transplant team at TGH and will be taken to the operating room for the surgical procedure The procedure will be performed under local anesthesia using a well-defined technique in the non-dominant brachioradialis muscle The length of the surgery is estimated to be less than an hour The patient will be recovering in PACU and then transferred back to the ward after the procedure is completed for continuation of the immunosuppressive therapy according to an established UHN Multiorgan Transplant protocol After monitoring overnight the patient will be discharged home the day following surgery
The patient will be discharged home on day 1 post surgery and follow up will be arranged on day 3 and day 7 in for monitoring of calcium profile and response to treatment Long-term follow-up for the patient will occur at 1 3 and 12 months post-operatively with the endocrine surgery endocrinology and transplant teams
The primary outcomes of the study are to assess improvement in hypoparathyroidism as assessed by biochemistry and patient symptoms with secondary outcomes including risk of surgical complications
This is a pilot prospective case-series It includes a cohort of patients with hypoparathyroidism who will undergo parathyroid transplantation from a neurologically deceased donor There is no control group in this study
Patients with permanent refractory hypoparathyroidism after total thyroidectomy will be entered in this study to undergo parathyroid transplantation from a neurologically deceased donor Inclusion criteria are patients who have had a prior total thyroidectomy with both biochemical hypoparathyroidism and symptomatic hypocalcemia numbness tingling or other neurologic symptoms requiring daily high dose calcium greater than 2000 mg per day vitamin D greater than 2 mcg of calcitriol per day supplementation andor intermittent IV calcium infusion Patients for inclusion must have failed this medical management after at least 1 year of treatment and meet standard criteria for receiving organ transplant
All patients will have at least one pre-operative clinic visit with the endocrine surgery endocrinology and transplant team for comprehensive assessment Baseline blood work will be conducted at this pre-operative visit as outlined in the study protocol The patient will also be evaluated by psychiatry and complete any necessary age appropriate comprehensive cancer screening as per standard transplantation protocol Completeness of pre-transplant vaccinations pneumococcus HBV influenza Tdap HAV will be reviewed and arranged in co-ordination with patients primary care provider as necessary If based on pre-transplant work up a participant is deemed to meet exclusion criteria and not be suitable for transplant this will be discussed with the participant and they will be withdrawn from the study Participants will be informed of the need to fulfill the previously listed standard transplant criteria during the informed consent process
Once a potential donor becomes available the transplant team will decide whether the donor is a match for a study participant A rigorous protocol for donor selection and transplantation was developed Donor criteria aimed at minimizing infectious and immunological risks HLA matching A history of hyperparathyroidism primary secondary or tertiary will also be screened for in the donor as the presence of hyperparathyroidism would be an exclusion criteria to procure their parathyroid glands for this study If the donor is a match for a study participant the participant will be contacted and timing of retrieval and patient arrival at TGH will be coordinated The procurement team will then with appropriate timing procure all parathyroid tissue using standard surgical techniques and the tissue will be kept in organ preservation solution in a sterile specimen cup with a cold ischemic time of less than 2 hours
The study participant will be admitted to the hospital under the Multi Organ Transplant team at TGH and will be taken to the operating room for the surgical procedure The procedure will be performed under local anesthesia using a well-defined technique in the non-dominant brachioradialis muscle The length of the surgery is estimated to be less than an hour The patient will be recovering in PACU and then transferred back to the ward after the procedure is completed for continuation of the immunosuppressive therapy according to an established UHN Multiorgan Transplant protocol After monitoring overnight the patient will be discharged home the day following surgery
The patient will be discharged home on day 1 post surgery and follow up will be arranged on day 3 and day 7 in for monitoring of calcium profile and response to treatment Long-term follow-up for the patient will occur at 1 3 and 12 months post-operatively with the endocrine surgery endocrinology and transplant teams
The primary outcomes of the study are to assess improvement in hypoparathyroidism as assessed by biochemistry and patient symptoms with secondary outcomes including risk of surgical complications
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None